Suturing device and method

ABSTRACT

A suturing device and method allows a physician to remotely suture biological tissue. The device includes an elongate body, first and second arms operably connected to the elongated body, whereby each arm mounts an end portion of a suture, and first and second needles, each needle having a distal end and being mounted such that the distal end of the needle is movable to engage respective end portions of said suture. The suturing apparatus further includes an actuator which drives the needles to engage the suture non-simultaneously.

RELATED APPLICATIONS

[0001] This application is continuation of U.S. Utility patentapplication Ser. No. 09/881,550, filed Jun. 14, 2001, which is acontinuation-in-part of International Patent Application No.PCT/US01/08050, filed Mar. 13, 2001 and published in English on Sep. 20,2001 as PCT Publication WO 01/67963, and a continuation-in-part of U.S.Utility patent application Ser. No. 09/524,211, filed Mar. 13, 2000,which is a continuation-in-part of U.S. Utility patent application Ser.No. 09/471,866, filed Dec. 23, 1999, which is a continuation of U.S.Pat. No. 6,117,144, filed Jan. 14, 1999, which is a continuation-in-partof U.S. Utility patent application Ser. No. 09/036,437, filed Mar. 9,1998, which is a continuation-in-part of U.S. Pat. No. 5,860,990, filedAug. 23, 1996, which claims the benefit of U.S. Provisional ApplicationNo. 60/002,769, filed Aug. 24, 1995. Each of the above-referenced patentapplications and issued patents is incorporated in its entirety byreference herein.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to suturing devices. Specifically,the present invention relates to suturing devices and methods forsuturing biological tissue that may not directly accessible to thephysician.

[0004] 2. Description of the Related Art

[0005] Physicians frequently use sutures to close cuts, punctures,incisions and other openings in various biological tissue, such as bloodvessels, of the human body.

[0006] In an arterial catheterization procedure, a relatively smallpercutaneous incision is made in the femoral or other artery. A catheteris inserted through the incision and directed along an arterial path toa target area, such as the heart, to perform one or more procedures,such as an angioplasty or angiogram. These procedures are designed to berelatively quick ‘outpatient’ procedures.

[0007] Upon completion of the catheterization procedure, the physiciantypically creates a ‘thrombus patch’ by applying direct pressure to thepatient's thigh to make the blood around the incision clot. Because thefemoral artery must not be completely blocked (occluded) by the appliedpressure, the physician commonly applies direct pressure by hand for thefirst twenty minutes after the procedure. During this time, thephysician can feel the pulse to assure the artery is not occluded.Afterwards, the physician usually turns the procedure over to anassistant who applies direct pressure using sandbags, clamps or otherdevices. A significant problem with this approach is that it isfrequently necessary to apply the pressure for an extended period oftime, such as twenty-four hours or longer.

[0008] Another problem with the thrombus patch method is that the highblood pressure in the artery can cause the thrombus patch to rupture orburst while direct pressure is being applied to the thigh or afterdirect pressure is removed. This requires the whole process to berestarted. If the patch ruptures and is not restored, the patient maybleed to death. Because thrombus patches frequently burst, the patientfrequently must remain in the hospital or catheterization lab overnightfor observation. Thus, these ‘out-patient’ procedures become‘in-patient’ procedures, simply because a thrombus patch it is difficultto create. Staying in the hospital increases patient discomfort andhospital expenses, which are often disproportionate to the actualmedical procedure performed.

[0009] Furthermore, if a thrombus patch cannot be formed, the physicianmay need to anesthetize the patient, occlude blood flow to the artery,make a large incision in the thigh to allow conventional suturing with aneedle, suture the artery with conventional means, restore blood flow tothe artery, and suture the incision in the thigh. This results inadditional discomfort and expenses for the patient.

[0010] While the above problems could potentially be avoided by suturingthe blood vessel immediately following the catheterization procedure,the size and location of the artery make suturing difficult.Specifically, the opening in the thigh is typically too small and toodeep to provide enough working space for suturing the artery usingconventional methods. Thus, in order to suture the vessel according toconventional methods, the opening in the thigh would have to besignificantly enlarged, potentially exposing the patient to additionalpain, scarring, and health risks.

SUMMARY OF THE INVENTION

[0011] The present invention addresses the above problems by providing asuturing device and method for suturing biological tissue, such as, forexample, an organ or blood vessel. The device is particularly wellsuited to suture an opening made in an artery, such as the femoralartery, following a catheterization procedure. The device eliminates theneed to apply pressure to a patient's thigh for an extended period oftime, and eliminates many of the complications and costs associated withthe creation of a thrombus patch.

[0012] One aspect of the invention relates to a suturing devicecomprising an elongate body and first and second arms. Each of said armshas a suture mounting portion which mounts an end portion of a suture.The arms are mounted on the elongate body such that said suture mountingportions are movable away from said body to a first position and towardssaid body to a second position. The suturing device further comprisesfirst and second needles, each of said needles having a distal end. Eachof said needles is mounted such that the distal end of the needle ismovable (i) in a proximal to distal direction from a position adjacentsaid elongate body to a position spaced outwardly from said body, and(ii) towards the suture mounting portion of one of the arms when in saidfirst position, wherein the respective distal ends of the first andsecond needles engage respective end portions of said suture. Thesuturing apparatus further comprises an actuator which drives theneedles in said proximal to distal direction such that the engagement ofthe respective end portions of the suture is non-simultaneous.

[0013] Another aspect of the invention relates to a suturing apparatuscomprising an elongate body and first and second arms. Each of said armshas a suture mounting portion which mounts an end portion of a suture,and each of said arms is operably connected to the elongate body suchthat said suture mounting portions are movable away from said body to afirst position and towards said body to a second position. The suturingapparatus further comprises first and second needles, each of saidneedles having a distal end. Each of said needles is mounted such thatthe distal end of the needle is movable (i) in a proximal to distaldirection from a position adjacent said elongate body to a positionspaced outwardly from said body, and (ii) towards the suture mountingportion of one of the arms when in said first position. The suturingapparatus further comprises an actuator comprising first and secondneedle drivers connected to drive the first and second needles,respectively, in said proximal to distal direction. Said needle driversare independently actuable such that the first needle is movableindependent of the second needle.

[0014] Another aspect of the present invention relates to a device forsuturing biological tissue. The device comprises an elongated body andan arm operably connected to the elongated body to move to an extendedposition away from the elongated body and to a retracted position towardthe elongated body. The arm has a mounting portion which mounts aportion of a suture, and has a tissue contacting surface which facesproximally when the arm is in the extended position. The tissuecontacting surface has a projecting portion configured to provideintimate contact with said tissue and to thereby inhibit lateralmovement of said arm when said tissue contacting surface is pressedagainst tissue. The device further comprises a needle having a distalend which is movable distally from a position adjacent the elongatedbody towards said mounting portion of said arm when the arm is in theextended position, such that said distal end engages said portion of thesuture mounted by said mounting portion.

[0015] Another aspect of the present invention relates to a suturingapparatus comprising an elongated body. The suturing apparatus furthercomprises an arm operably connected to the elongated body and movablerelative to the elongated body to an extended position away from theelongated body and to a retracted position towards the elongated body.The arm has a mounting portion which mounts a portion of a suture. Thesuturing apparatus further comprises a needle movable relative to theelongated body. The needle has a distal end movable from a positionadjacent the elongated body towards the mounting portion of the arm whenthe arm is in the extended position, such that the distal end engagesthe portion of the suture mounted by the mounting portion of the arm.The suturing apparatus further comprises a patch which is tethered bythe suture.

[0016] Another aspect of the present invention relates to a method ofsuturing. The method comprises providing an elongate body having firstand second arms which mount first and second portions, respectively, ofa suture. The method further comprises engaging the first and secondportions of the suture with first and second needles, respectively, bydriving the first and second needles towards the first and second arms,respectively, in a proximal to distal direction. The engaging comprisesengaging the first portion of suture with the first needle prior toengaging the second portion of the suture with the second needle.

[0017] Another aspect of the present invention relates to a method ofoccluding a septal defect. The method comprises inserting a distal endportion of an elongated body into an opening in a living being. Themethod further comprises positioning the distal end portion in a firstlocation adjacent a first tissue portion in proximity to the septaldefect. The method further comprises deploying a first needle within theelongated body so as to draw a first end of a suture through the firsttissue portion. The method further comprises moving the distal endportion to a second location displaced from the first location andpositioning the distal end portion adjacent a second tissue portion inproximity to the septal defect. The method further comprises deploying asecond needle within the elongated body so as to draw a second end ofthe suture through the second tissue portion. The method furthercomprises using the suture to secure a patch across the septal defect.

[0018] Another aspect of the present invention relates to a method ofsuturing. The method comprises inserting a distal end portion of anelongated body into an opening in a living being. The method furthercomprises positioning the distal end portion in a first locationadjacent a first tissue portion. The method further comprises deployinga first needle within the elongated body so as to draw a first end of asuture through the first tissue portion. The method further comprisesmoving the distal end portion to a second location displaced from thefirst location and positioning the distal end portion adjacent a secondtissue portion. The method further comprises deploying a second needlewithin the elongated body so as to draw a second end of the suturethrough the second tissue portion. The method further comprises usingthe suture to secure a patch to the first and second tissue portions.

[0019] Another aspect of the present invention relates to a method ofsuspending a biological structure. The method comprises positioning adistal portion of an elongated body adjacent the biological structure tobe suspended. The method further comprises positioning a first armoperably connected to the elongated body on one side of the biologicalstructure, the first arm releasably holding a first end portion of asuture. The method further comprises extending a first needle toward thefirst end portion of the suture in the first arm. The first needle moveson an opposite side of the biological structure such that when the firstneedle engages the first end portion of the suture, the biologicalstructure is encircled by the first arm, the first needle, and theelongated body. The method further comprises positioning a second armoperably connected to the elongated body adjacent a tissue portion. Thesecond arm releasably holds a second end portion of the suture. Themethod further comprises extending a second needle through the tissueportion to engage the second end portion of the suture in the secondarm. The method further comprises drawing the first end portion andsecond end portion of the suture toward the elongated body. The methodfurther comprises tying the first end portion and second end portion ofthe suture to suspend the biological structure to the tissue portion.

[0020] Another aspect of the present invention relates to a method ofplacing a suture around the exterior of a biological structure. Themethod comprises advancing an elongate suturing device having anelongate body distally towards the biological structure. The methodfurther comprises positioning a first suture portion mounted on theelongate device so that the first suture portion is proximate thebiological structure. The method further comprises advancing a sutureretrieving member of the elongate device past the biological structurewithout piercing the biological structure. Advancing the sutureretrieving member comprises moving the suture retrieving member with thebiological structure between the suture retrieving member and theelongate body. Advancing the suture retrieving member further comprisescoupling the suture retrieving member to the first suture portion. Themethod further comprises drawing the first suture portion away from thebiological structure by moving the suture retrieving member in adirection away from the biological structure. The method furthercomprises drawing a second suture portion away from the biologicalstructure by moving at least a portion of the elongate device from thebiological structure, whereby the suture extends in a loop around thebiological structure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021]FIG. 1A illustrates one embodiment of the present invention in anexemplary use environment.

[0022]FIG. 1B illustrates a cross-sectional view of the device in FIG.1A in an exemplary use environment, such as a patient's thigh.

[0023]FIG. 1C illustrates another embodiment of the present invention inthe exemplary use environment of FIG. 1A.

[0024]FIG. 1D illustrates a cross-sectional view of the device in FIG.1C in an exemplary use environment, such as a human thigh.

[0025]FIG. 2 is a partial cross-sectional view of the suturing devicedepicted in FIG. 1A having a suture catch assembly and a sutureintroducer housing.

[0026]FIG. 3 is a bifurcated perspective view of the suture introducerhousing of FIG. 2.

[0027]FIG. 4A is a partially schematic perspective view of the sutureclasp arms of FIG. 2.

[0028]FIG. 4B is a partial cross-sectional view of one configuration ofsuture clasp arms.

[0029]FIG. 4C is a partial cross-sectional view of another configurationof suture clasp arms.

[0030]FIG. 4D is a partial cross-sectional view of yet anotherconfiguration of suture clasp arms.

[0031]FIG. 4E is a partial cross-sectional view of yet anotherconfiguration of suture clasp arms.

[0032]FIG. 5 is an elevational view of one configuration of a sutureclasp arm.

[0033]FIG. 6 is an elevational view of another configuration of a sutureclasp arm.

[0034]FIG. 7 is an enlarged elevational view of one configuration of asuture clasp.

[0035]FIG. 8 is an enlarged elevational view of a suture having bandscrimped thereon.

[0036]FIG. 9 is an enlarged elevational view of another configuration ofa suture clasp.

[0037]FIG. 10 is an elevational view of the suture clasp of FIG. 9illustrating the action of a suture and the suture clasp as the sutureis being removed from the suture clasp.

[0038]FIG. 11A is a cross-sectional top view of one configuration of asuture introducer housing, suture clasp arms, a suture, and a triangularspreader.

[0039]FIG. 11B is a cross-sectional side view of the suture introducerhousing and triangular spreader of FIG. 11A.

[0040]FIGS. 12 and 13 are partial cross-sectional views of anotherconfiguration of a spreader for deploying the suture clasp arms.

[0041]FIG. 14 is a partial cross-sectional view of an alternateconfiguration of the device for deploying the suture clasp arms.

[0042]FIG. 15 is a partial cross-sectional view of an alternateconfiguration of suture clasp arms.

[0043]FIG. 16 is a partial cross-sectional view of the device of FIG. 15illustrating the suture clasp arms in a deployed position.

[0044]FIG. 17 is a bifurcated perspective view of the suture catchassembly of FIG. 2.

[0045]FIG. 18 is a partial cross-sectional view of an alternateconfiguration of the suture catches and the suture clasp arms.

[0046]FIG. 19 is a schematic perspective view of a needle tip and oneconfiguration of a suture catch.

[0047]FIG. 20 is a cross-sectional view of the suture catch of FIG. 19taken along line 19-19 illustrating the position of a suture fittingcaptured by the suture catch.

[0048]FIG. 21 is a cross-sectional top view of the suture catch of FIG.19 taken along line 20-20.

[0049]FIG. 22 is a schematic illustration of another configuration of asuture fitting.

[0050]FIG. 23 is a side view of a suture clasp arm used to hold thesuture fittings of FIGS. 20 and 22.

[0051]FIG. 24 is a rear elevational view of a needle tip with analternate configuration of the suture catch.

[0052]FIG. 25 is a cross-sectional view of the needle tip of FIG. 24taken along line 24-24 of FIG. 24.

[0053]FIG. 26 is a partial cross-sectional side view of an alternateconfiguration of a suture clasp arm to hold a suture fitting.

[0054]FIG. 27 is an end view of the suture clasp arm of FIG. 26.

[0055]FIG. 28 is a perspective view of a three-sector arm actuatorassembly with a catch in a distal position.

[0056]FIG. 29 is a perspective view of a button of the assembly of FIG.28.

[0057]FIG. 30 is a perspective view of a guide of the assembly of FIG.28.

[0058]FIG. 31 is a perspective view of the catch of the assembly of FIG.28.

[0059]FIG. 32 is a perspective view of the assembly of FIG. 28 with thecatch in a proximal position.

[0060]FIG. 33 is a schematic partial cross-sectional view of theassembly of FIG. 28 with the catch in a distal position.

[0061]FIG. 34 is a partial cross-sectional view of the suture introducerhousing of FIG. 2 with the introducer over the housing.

[0062]FIG. 35 is a partial cross-sectional view of the suture introducerhousing of FIG. 2 with the suture clasp arms deployed.

[0063]FIG. 36 is a partial cross-sectional view of the suture introducerhousing and suture catch assembly of FIG. 2 illustrating the operationof the suture catch assembly.

[0064]FIG. 37 is a partial cross-sectional view of the suture introducerhousing and the suture catch assembly of FIG. 2.

[0065]FIG. 38 is a schematic view of a vessel illustrating the locationof the suture.

[0066]FIG. 39 is a schematic cross-sectional view of the vessel of FIG.38 taken along line 40-40.

[0067]FIG. 40 is a partial schematic cross-sectional view of oneconfiguration of the suturing device having a detachable arm deploymenthandle.

[0068]FIG. 41 is a cross-sectional view of the embodiment depicted inFIG. 1C with the distal end inserted through an arterial wall.

[0069]FIG. 42 is a cross-sectional view of the device of FIG. 41 withthe suture clasp member partially deployed.

[0070]FIG. 43A is a perspective view of a suture clasp member, anactuator and a hollow elongated body of FIG. 41.

[0071]FIG. 43B is an exploded view of the suture clasp member, pivot pinand actuator of FIG. 42.

[0072]FIG. 43C is a perspective view of a two-piece suture clasp member.

[0073]FIG. 43D is a cross-sectional view of the two-piece suture claspmember of FIG. 43C and a spreader within the suture introducer head ofFIG. 41.

[0074]FIG. 44 is a perspective view of the suture introducer head andsuture clasp member of FIG. 41.

[0075]FIG. 45 is perspective view of the device of FIG. 44 with thesuture clasp member partially deployed.

[0076]FIG. 46 is a rear perspective view of the device of FIG. 44.

[0077]FIG. 47 is cross-sectional view of the device of FIG. 41 with thesuture clasp member fully deployed.

[0078]FIG. 48 is a cross-sectional view of another embodiment of thepresent invention.

[0079]FIG. 49 is a cross-sectional view of one embodiment of a handlecapable of being attached to the proximal end of the device of FIG. 41,the device of FIG. 48 or the device of FIG. 52A.

[0080]FIG. 50 is a perspective view of the handle of FIG. 49.

[0081]FIG. 51 is a cross-sectional view of another embodiment of ahandle capable of being attached to the proximal end of the device ofFIG. 41, the device of FIG. 48 or the device of FIG. 52A.

[0082]FIG. 52A is a perspective view of the suture introducer head andthe hollow elongated body of FIG. 41 with another embodiment of thesuture clasp arms.

[0083]FIG. 52B is a cross-sectional view of the device of FIG. 52A.

[0084] FIGS. 53A-53B are perspective views of one configuration of thesuture clasp member of FIG. 52A.

[0085]FIG. 54 is a perspective view of the device of FIG. 52A with thesuture clasp member partially deployed.

[0086]FIG. 55 is a perspective view of the device of FIG. 52A with thesuture clasp member fully deployed.

[0087]FIG. 56 is a perspective view of the device of FIG. 52A with thesuture clasp member fully deployed and needles engaging the suture claspmember.

[0088]FIG. 57 is a perspective view of the handle of FIG. 49.

[0089] FIGS. 58-59 are perspective views of a four-arm suture claspmember used with the device of FIGS. 1C-1D.

[0090]FIG. 60 is an exploded view of another embodiment of a handlecapable of being attached to the proximal end of the device of FIG. 41,the device of FIG. 48 or the device of FIG. 52A.

[0091]FIG. 61 is a perspective view of the handle of FIG. 60.

[0092]FIG. 62 is a perspective view of another configuration of thesuture introducer head and the hollow elongated body of FIG. 52A withsix suture clasp arms.

[0093]FIG. 63 is a perspective view of the device of FIG. 62 with thesuture clasp arms fully deployed.

[0094]FIG. 64 is a perspective view from the distal end of the device ofthe six suture clasp arms of FIG. 62.

[0095]FIG. 65 is a perspective view of the device of FIG. 62 with thesuture clasp arms fully deployed and a set of needles engaging thesuture clasp arms.

[0096]FIG. 66 is a perspective view from the distal end of anothersuture device configuration of the present invention with four sutureclasp arms.

[0097]FIG. 67 is a perspective view of the suture device of FIG. 66 withthe suture clasp arms fully retracted.

[0098]FIG. 68 is a perspective view of the suture device of FIG. 66 withthe suture clasp arms partially deployed.

[0099]FIG. 69 is a perspective view of the suture device of FIG. 66 withthe suture clasp arms fully deployed and a set of needles.

[0100] FIGS. 70-71 illustrate a removable sheath that may be used withthe suture devices shown in FIGS. 1A-69.

[0101] FIGS. 72-73 illustrate occlusion devices that may be used withthe suture devices shown in FIGS. 1A-69.

[0102]FIG. 74A is an exploded cross-sectional view of another embodimentof a handle capable of being attached to the proximal end of the deviceof FIG. 41, the device of FIG. 48 or the device of FIG. 52A.

[0103]FIG. 74B is an exploded cross-sectional view of another embodimentof a handle adapted to separately actuate the first and second needles.

[0104]FIGS. 75A and 75B are exploded, cross-sectional, perspective viewsof the handle of FIG. 74A.

[0105]FIG. 76A is an exploded, cross-sectional, perspective view of thehandle of FIG. 74B.

[0106] FIGS. 76B-D schematically illustrate various embodiments of theneedle drivers adapted to separately actuate the first and secondneedles.

[0107]FIG. 77 illustrates the suture device of FIG. 56 adapted to move afirst needle distally to engage a first suture clasp arm before moving asecond needle distally to engage a second arm.

[0108]FIG. 78 illustrates the suture device of FIG. 77 with the secondneedle moving distally.

[0109]FIG. 79 illustrates the suture device of FIG. 77 with the firstneedle piercing a first biological tissue portion and engaging the firstsuture clasp arm.

[0110]FIG. 80 illustrates the suture device of FIG. 77 with the secondneedle piercing a second biological tissue portion and engaging thesecond suture clasp arm.

[0111]FIG. 81 illustrates the first and second biological tissueportions being drawn together by a suture inserted by the suture deviceof FIG. 77.

[0112]FIG. 82A illustrates the suture device of FIG. 77 with a patchdeployed from the elongated body.

[0113]FIG. 82B illustrates the patch of FIG. 82A occluding the suturesite.

[0114]FIG. 83A illustrates a patch connected to the ends of the suturebefore distally sliding the patch toward the suture site.

[0115]FIG. 83B illustrates the patch of 83A occluding the suture sitewith a knot securely holding the patch in place.

[0116]FIG. 84 illustrates a patch with two pairs of sutures through thepatch.

[0117]FIG. 85 illustrates a suture device with a steerable portion and afirst needle piercing a first biological tissue portion.

[0118]FIG. 86 illustrates the suture device of FIG. 85 with a secondneedle piercing a second biological tissue portion.

[0119] FIGS. 87-102 illustrate methods of forming suture ends of asuture which may be used with the suture devices described herein, inwhich:

[0120]FIG. 87 shows a strand of material being brought into a stream ofhot gas;

[0121]FIG. 88 shows a distal end of the strand being thermally deformedto form a deformed region such as a globule;

[0122]FIGS. 89 and 90 show a die for flattening the deformed region;

[0123]FIG. 91 shows the strand after the deformed region has beenflattened;

[0124]FIG. 92 shows the strand after excess material has been cut awayfrom the deformed region;

[0125]FIG. 93 shows the strand after an eyelet has been formed in theflattened, deformed region;

[0126]FIG. 94 shows a suture in which eyelet portions have been formedat both ends of the suture;

[0127]FIG. 95 shows the deformed region placed between two blocks havingrecessed portions therein;

[0128]FIG. 96 shows the deformed region after it has been squeezedbetween the blocks to form a cylindrically shaped member;

[0129]FIG. 97 shows a hole being formed in the deformed region with ahypotube;

[0130]FIG. 98 shows the formed hole in the deformed region, resulting ina cup-like member at the end of the strand;

[0131]FIGS. 99 and 100 show views of a one embodiment of a surgicalneedle to be used with the cup-like member of FIG. 98;

[0132]FIG. 101 shows the surgical needle having entered the cup-likemember and secured to it; and

[0133]FIG. 102 shows an embodiment having cup-like members at both endsof the suture.

[0134]FIG. 103A shows a side view of the distal portion of the devicewith one end portion of the suture captured by a needle extended throughthe tissue structure and a second end portion of the suture loopedaround a second tissue structure .

[0135]FIG. 103B shows a side view corresponding to FIG. 103A once theend portions of the suture have been tied together and tightened.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0136] The present invention provides a suturing device for suturingbiological tissue. The suturing device may be used to seal a bloodvessel following an interventional catheterization procedure, such as anangiogram. FIGS. 1A-1B illustrate one embodiment of the presentinvention in an exemplary use environment. As depicted by FIGS. 1A-1B,the physician makes an initial incision 20 in the upper thigh 12 of apatient 2. The physician then inserts a needle (not shown) into theincision 20. When blood bleeds back from the insertion, the physicianknows the needle has pierced the femoral artery 16. The physician theninserts a guidewire (not shown) through the needle and into the artery.The physician may take the needle out and insert a plastic needle (notshown) over the guidewire once the guidewire is in place. The guidewiremay then be taken out.

[0137] With this needle in place, the physician can insert a cathetersheath introducer (CSI) 6, also called an introducer sheath. Thisintroducer sheath 6 is typically a single lumen catheter with a valve onits proximal end. The valve is used to prevent extraneous bleed back orto introduce medication into the patient's body. The vessel incision 26provides access for medical instruments and probes inside the arterialvessel 16. Instruments may be inserted into artery 16 via the introducersheath 6 to perform various procedures in the body.

[0138] In FIG. 1A, the suture assembly 4 consists of the suture catchassembly 36 (described below), the suture introducer housing 24, and theintroducer sheath 6. FIG. 1B illustrates a cross-sectional view of thedevice depicted in FIG. 1A in an exemplary use environment, such as apatient's thigh. After the medical procedure described above, thephysician withdraws the CSI 6 and inserts the suture catch assembly 36and the suture introducer housing 24 through the first incision 20. Thesuture catch assembly 36 and suture introducer housing 24 pass throughthe flesh 14 of the patient's thigh 12 and through the second incision26 into the femoral artery 16. In another method, the physician mayfirst insert the suture introducer housing 24, remove the CSI 6, andthen insert the suture catch assembly 36.

[0139]FIGS. 1C and 1D illustrate another embodiment of the presentinvention in the exemplary use environment of FIG. 1A. Unlike the deviceillustrated in FIGS. 1A-1B, the device illustrated in FIGS. 1C-1D doesnot require the removal of the CSI 6 in order for the device to deploy asuture. Several embodiments of the device shown in FIGS. 1A and 1B willnow be described with reference to FIGS. 2-40. The device depicted inFIGS. 1C-1D will thereafter be described in further detail below withreference to FIGS. 41-50.

[0140] Embodiments of FIGS. 1A-1B and 2-40

[0141]FIG. 2 shows one embodiment of the suturing device for suturingvessel walls and other biological tissue. Preferably, the device is foruse in suturing arterial vessel walls 22. However, the device could beused to suture other tissue such as a patent ductus arteriosus, a patentforamen ovale, a heart defect, a puncture wound, and the like. Thesuturing device comprises a suture introducer housing 24 for insertioninto an opening 26 in the arterial wall 22.

[0142] Suture clasp arms 28, 30 are deployably housed in the housing 24during insertion. After insertion into the vessel 16, the arms 28, 30are deployed to the position shown in FIG. 2. When deployed, the sutureclasp arms 28, 30 extend outside the circumference of the sutureintroducer housing 24. In certain embodiments, the arms 28, 30 extendfrom the housing in a symmetric configuration, in which each arm 28, 30has the same angle with respect to the axis of the housing 24.Alternatively, in other embodiments, each arm 28, 30 can extend from thehousing in an asymmetric configuration, in which each arm 28, 30 has adifferent angle with respect to the axis of the housing 24. Furthermore,in certain embodiments, the arms 28, 30 are spaced equidistantly aroundthe circumference of the housing 24. Equidistant spacing as used hereinmeans that the azimuthal angle between the two arms 28, 30 is 180degrees, where the azimuthal angle between the two arms 28, 30 is theangle between the plane defined by the axis of the housing 24 and thefirst arm 28 and the plane defined by the axis of the housing 24 and thesecond arm 30. Alternatively, in still other embodiments, the arms 28,30 are spaced non-equidistantly around the circumference of the housing24 (e.g., the azimuthal angle between the two arms 28, 30 is 90degrees).

[0143] Each arm has at least one suture clasp 32, schematicallyillustrated, for clasping a suture 40. A penetrating mechanism,generally designated 34, is provided for penetrating the vessel wall 22.The penetrating mechanism 34 is provided on either the suture introducerhousing 24 or on a suture catch assembly, generally designated 36. When,as shown in FIG. 2, the penetrating mechanism 34 is part of the suturecatch assembly 36, the penetrating mechanism 34 also comprises suturecatches 38 for catching the suture 40 and dislodging it from the sutureclasps 32. The suture catch assembly 36 operates to pull the suture 40held by the suture catches 38 through the vessel wall 22. After the endsof the suture 40 are pulled outside the vessel wall 22, the introducerhousing 24 can be removed and the suture 40 tied to close the vesselopening 26.

[0144]FIG. 3 shows one configuration where the suture introducer housing24 is a generally cylindrical and thin walled hypo tube. The term “hypotube” is used to describe a hollow elongated cylindrical member with athin wall such that the inner diameter and outer diameter vary by arelatively small amount in the range of few thousandths of an inch totens of thousandths of an inch. The outer surface 42 of the housing 24comprises a key way groove 44 (exaggerated for clarity) to align thehousing 24 with a key 46 (FIG. 17) on the inner surface 48 of the suturecatch assembly 36. An arm actuation assembly 170, to be described below,for deploying the suture clasp arms 28, 30 protrudes from the proximalend of the housing 24, and an actuating wire or rod 50 extends from theactuation assembly 170 through the housing 24 to the suture clasp arms28, 30.

[0145]FIG. 2 shows one configuration where the suture clasp arms 28, 30are attached to the distal end 54 of the actuating rod 50. In thisconfiguration, the arms 28, 30 are pivotally attached to the actuatingrod 50 and pivot around pivot shaft 56. The suture 40 is held inside thehousing 24 and is positioned underneath the spreader 102, so that it canbe removed from the entire housing 24. The arms 28, 30, which are shownin more detail in FIGS. 4A and 4B, terminate with the suture clasps 32(schematically illustrated). Each arm 28, 30 has an elongated body 58which attaches to the pivot shaft 56 at one end and to the suture clasp32 at the other. The length of the body 58 controls how far beyond thecircumference of the suture introducer housing 24 the arms 28, 30 extendwhen they are deployed by the actuating rod 50.

[0146] As illustrated in FIG. 4B, the proximal sides of the suture clasparms 28, 30 near the slots 76 which receives the suture 40 aresubstantially parallel to the vessel wall 22 when the arms 28, 30 aredeployed within the vessel 16. The proximal sides of the suture clasparms 28, 30 can then provide mechanical support for the vessel wall 22in the region of the opening 26. In an alternative configuration, asillustrated in FIG. 4C, the proximal sides of the suture clasp arms 28,30 have an upward curvature near the slots 76, thereby defining aproximally projecting portion on the proximal side of each of the arms28, 30. In this configuration, the proximal side of the arms 28, 30provide mechanical support for the vessel wall 22 while the proximallyprojecting portions provide an improved purchase on the vessel wall 22.This configuration then reduces the probability of slippage of the arms28, 30 relative to the vessel wall 22 when the arms 28, 30 are deployedwithin the vessel 16. Other configurations can have multiple proximallyprojecting portions on each arm 28, 30, or can have proximallyprojecting portions which are protuberances on the proximal sides ofarms 28, 30 without upward curvature. These proximally projectingportions can have various cross-sectional shapes, such as triangular ortrapezoidal. Still other embodiments can have relatively smallproximally projecting portions which have areas smaller than the area ofthe proximal side of the arms 28, 30. In addition, other embodimentshave proximally projecting portions which are in proximity to theportion of the arms 28, 30 which mount the end portions of the suture,such as the slots 76 illustrated in FIG. 4C. The proximally projectingportions can also be located in proximity to the ends of the arms 28, 30away from the pivot shaft 56.

[0147] Similarly, other configurations of suture clasp arms 28, 30 canhave proximally projecting portions on each of the arms 28, 30. FIG. 4Dillustrates such proximally projecting portions on arms 28, 30 such asthose described below in conjunction with FIGS. 43-47, and FIG. 4Eillustrates such proximally projecting portions on arms 28, 30 such asthose described below in conjunction with FIGS. 52-56.

[0148]FIG. 5 shows an alternate configuration of the arms 28, 30. InFIG. 5, the arms 28, 30 are Y-shaped with an offset body 64, and thereis a suture clasp at each tip 60, 62 of the Y-shaped arm. The body 64 isoff center from the tips 66, 68, so that a complimentary arm can pivoton the same pivot shaft 56 without interference. Thus, the Y-shape ofthe arms allows them to pivot beside each other outwardly from andinwardly to their undeployed position without interference from theother arm. The Y-shape of the arm also provides an open area or suturecatch receiving area 80 into which the suture catch 30 fits to catch thesuture 40. Other arm shapes such as the h-shaped arm shown in FIG. 6 mayprovide the same or additional benefits. The h-shaped arm has a body 70with an aperture 71 for attachment to a pivot shaft 56 and each tip 72,74 of the arm is provided with a suture clasp. The body of the h-shapedarm is positioned all the way to the side of the arm and functionssimilarly to the Y-shaped arm. The configuration of the suture clasp armshown in FIG. 6 also has a suture catch receiving area 80A.

[0149]FIGS. 7 and 8 illustrate one configuration of the suture clasp 32,which comprises a key hole shaped slot 76 which widens toward the end ofthe tip to receive the suture 40. As illustrated in FIG. 4, a loop 78 istied in each end of the suture 40. The loop 78 is sized to fit tightlybetween the suture clasps 32 on each arm 28, 30. The key hole shapedslot 76 is elongated and narrows away from the end of the tip 60 to aneck 82 having a width W. The end 84 of the slot 76 is circular with adiameter greater than the neck width W. The diameter of the circular end84 of the slot 76 is sized to receive either the outer diameter of asuture 40, shown in FIG. 8, or the outer diameter of cylindrical bands86 which are crimped onto the suture 40. The suture 40 or the bands 86have an outer diameter approximately the same size as the diameter ofthe end of the slot 76 but smaller than the neck width W. Because thediameter of the bands 86 (or suture 40) is smaller than the width of theneck 83, the bands 86 snap into the end of the slot 76 and are securelyheld therein until removed by the suture catch 38. In an alternateconfiguration (FIG. 14), it is desirable for the slots 76 to openupwardly when they are in the deployed position, so that the suture 40is pulled straight up out of the slots 76.

[0150]FIG. 9 shows another configuration of the suture clasps 32. Inthis configuration, the arm 28, 30 comprises a shaft 88 extending to aplate or bar 90. A resilient element 92, such as a spring, is attachedat each end of the bar 90, and tips 94 are attached to the end of eachresilient member 92. The tips 94 have slots as previously described andshown by FIG. 7. The suture 40 has beads 96 fixed thereto or knots tiedtherein. The beads are spaced apart by a distance just less than thedistance between the outer edges 98 of the tips 94. With this distancebetween the beads 96, the tips 94 must be slightly bent toward eachother thereby loading the resilient members 92 to receive the suture 40.When the tips 94 are pulled inwardly and the resilient members 92loaded, the suture 40 is held in place by the force from the resilientmembers 92. Therefore, the suture 40 is held in tension between the tips94.

[0151] When the suture catch 38 is guided through the suture catchreceiving area 100, the resilient members 92 are further deformed as thesuture 40 is forced to make an arc to receive the suture catch 38 asillustrated in FIG. 10. The resilient members 92 then bend in thedirection that the suture catch 38 is retracted, so that the suture 40slides smoothly out of the clasp 32. If desired, the outer edges 98 ofthe tips may be indented 99 to receive and more securely hold the beads96 or knots on the suture 40.

[0152]FIG. 14 illustrates an alternate configuration of the suture claspslot. The slot 127 opens upwardly toward the penetrating mechanisminstead of transverse to the penetrating mechanism as in the previousconfiguration.

[0153] In FIG. 2, the suture clasp arms 28, 30 are deployed when theactuation rod 50 forces the arms 28, 30 downward to a triangularspreader 102. FIG. 11A is a cross-sectional top view of oneconfiguration of the suture introducer housing 24, the clasp arms 28,30, the suture 40, and a triangular spreader 102. FIG. 11A shows thetriangular spreader 102 extending across a diameter line of the sutureintroducer housing 24. The spreader 102 may be shaped in alternativeforms other than a triangle.

[0154]FIG. 11B is a side view of one configuration of the sutureintroducer housing 24, the triangular spreader 102 and the direction ofthe clasp arms 28, 30 as they extend downward into the blood vessel 16.One vertex 104 of the triangular spreader 102 is positioned centrally inthe housing 24 and extends upwardly. The triangle is preferablyisosceles with respect to the upward extending vertex 104, so that thearms 28, 30 spread uniformly when they engage the spreader 102 and pivotabout the pivot shaft 56. Each arm 28,30 ultimately extends the samedistance beyond the circumference of the housing 24. The surfaces of thespreader 102 and arms 28, 30 which engage to deploy the arms arepreferably smooth, so that the deployment of the arms 28, 30 is smooth.

[0155] Another configuration for deploying the suture clasp arms isshown in FIGS. 12 and 13. The arms 106 are pivotally attached to theactuating rod 50 with a pivot shaft 109, and a circular spreader bar 108or cam pin extending across a diameter line of the housing 110. When theactuating rod 50 forces the suture clasp arms 106 to engage the circularspreader 108, they are forced into the deployed position of FIG. 13. Toobtain smooth deployment of the arms 106, the bottom surface 107 of thearms 106 forms a curved camming surface for engaging the circularspreader 108. The housing 110 has two slit shaped openings 112 evenlyspaced around the circumference of the housing 110 through which thearms 106 extend into the deployed position. The end of the openings 112also forms a stop 113 to prevent the arms 106 from moving past thedeployed position. With the openings 112 in the housing 110, the shapeof the arms 106 is simplified. Because the arms 106 do not have to curvedown out of the housing 110, the arms 106 are straighter than in theprevious configurations.

[0156] An alternative means for deploying the clasp arms is illustratedin FIG. 14. Each clasp arm comprises an upper lever arm 114 pivotallyattached at one end to the actuating rod 50 with a pivot shaft 116 and alower pivot arm 118 pivotally attached to the other end of the upperlever arm 114. The lower pivot arm 118 rotates around a pivot shaftspreader 120 which is attached to the housing 122 and extends across adiameter line of the housing 122. When the actuating rod 50 is forceddistally farther down the housing 122, the lower pivot arms 118 areforced to pivot around the pivot shaft spreader 120, and the arms 118are deployed to the position shown in solid lines. As the lower pivotarm 118 rotates, the upper lever arm 114 rotates relative to the pivotshaft 116, and the junction 124 between the upper and lower arms istranslated downward (distally) and outwardly toward the circumference ofthe housing. When the actuating rod 50 is retracted from the housing,the junction is moved upward and centrally in the housing 122, and thelower pivot arm 118 is rotated to the retracted position shown inpartial dashed lines.

[0157] The housing 122, similar to the configuration of FIG. 13, hasslit openings 126. The openings 126 extend a greater distance along thelength of the housing 122 than in FIG. 13 to allow room for the lowerpivot arm 118 to exit the housing 122 and provide sufficient room forthe junction 124 to move outwardly.

[0158] A stop 129 attached to the upper lever arm 114 is placed betweenthe upper lever arm 114 and the lower pivot arm 118 to prevent the armsfrom moving past the deployed position. Alternatively, the stop 129 canbe inherent in the lower pivot arm 118 and upper lever arm 114. Thiswould include a notch on the side of one of the arms which the other armwould contact to limit the movement of the arms.

[0159]FIG. 14 illustrates the use of a sealing member 52 inside thesuture introducer housing 24. The sealing member 52 prevents blood flowback through the housing 122.

[0160] Still another configuration of the clasp arm deployment mechanismis illustrated in FIGS. 15 and 16. In this configuration, a singleresilient arm 128 is attached to the actuating rod 50. The resilient arm128 is predisposed in a deployed configuration shown in FIG. 16. Whenthe arm 128 is retracted into the housing 24, the prongs 130 of the arm128 are elastically deformed inwardly. When the arm 128 is moved out ofthe housing 24 by the actuating rod 50, the prongs 130 expand to thepredisposed deployed position. This configuration is easily adaptable tohaving four prongs 130 spaced at ninety degrees. Thus, any configurationand number of prongs can be incorporated into the device depending onthe specific needs of the application.

[0161]FIGS. 2 and 17 illustrate a preferred configuration of the suturecatch assembly 36 with a generally cylindrical outer tube 132, which, asdescribed above, includes a key 46 to mate with the key way groove 44 ofthe suture introducer housing 24. The inner diameter of the tube 132 issized to fit over the outer diameter of the suture introducer housing 24without any interference. This fit does not need to be tight because thesuture catch assembly 36 is not inserted into the opening 26 of thevessel 16. Therefore, there is no need to prevent the flow of bloodbetween the suture housing 24 and the suture catch assembly 36. Also,the fit between the suture catch assembly 36 and the suture introducerhousing 24 does need to be close enough to assure that the suture catch38 is properly aligned with respect to the suture clasps 32. Properalignment is accomplished by a close fit between the key 46 and the keyway groove 44.

[0162] The catch assembly 36 comprises a plurality of, preferably two,apertures 134 for slidably receiving respective needles 136 or otherpenetration members. The apertures 134 extend through the length of thetube 132 and may be equally spaced around the circumference of the tube132 in one configuration of the device.

[0163] The blunt ends 138 of the needles 136 are connected to anactivation ring 140, and springs 142 are interposed between theactivation ring and the tube 132. The springs 142 hold the needles in aretracted position so that the needle points are within the tube 132.With the needles 136 biased in a retracted position by the springs, thesuture catch assembly 36 can be handled without the chance of inflictingan unintentional puncture wound.

[0164] At least one stop 144 is fixed on the inner surface 48 of thetube 132 and engages the top 146 of the suture housing 24 to fix therelative position between the suture housing 24 and the catch assembly36. Because the spring 142 can only be compressed a certain distance,the depth of entry of the needles 136 into the vessel 16 is controlledto prevent puncturing the opposite side of the vessel 16. Furthermore,the fixed relative position between the suture housing 24 and catchassembly 36 assures that the needles 136 pass far enough into the suturecatch receiving area 80 to catch the suture 40.

[0165] Near the end of each needle 136 is the suture catch 38. Thesuture catch 38 is an aperture extending to the outer edge on one sideof the needle 136. The aperture is slot shaped and angled upwardlytoward the proximal end of the device. While the needles are beingpulled from the vessel 16, the suture 40 is pulled to the bottom of thesuture catch 38 where it cannot come loose.

[0166]FIG. 18 shows an alternate configuration of a penetratingmechanism, generally designated 150, with the suture introducer housing152. The penetrating mechanism comprises needle points 154 press fitonto arms 156. The end of the arms 156 opposite the needle points 154are fixed to the actuating rod 50. The arms 156 are made of a resilientmaterial exhibiting shape memory such as NITENOL, and the arms 156 areat rest in a deployed position shown in dashed lines. When the arms 156are within the suture housing 152, they are deformed to fit within thehousing 152. When the actuating rod 50 pushes the needle points 154beyond the suture housing, the arms 156 return to their at-rest positionwith the needle points 154 beyond the circumference of the housing 152.The suture 40 is attached to the needle points 154. The needle points154 are then pulled upward by the actuating rod 50 toward the vesselwall 22, thereby penetrating the vessel wall 22 from within the vessel16.

[0167] The suture catch 158 has a V-shaped notch 160 with rounded tips162. There is a slit 164 extending up from the vertex of the notch 160.The rounded tips 162 prevent the suture catch 158 from inadvertentlypuncturing the vessel wall 22. The needle points 154 fit into thenotches 160 and cause the notches 160 to open farther along the slits164. After the needle points 154 are inside a cavity 166 within thesuture catch 158, the notch 160 collapses to its original shape andtraps the needle points 154 inside. The suture catch 158 is then pulledproximally until the press fit between the needle points 154 and thearms 156 is overcome, and the needle points 154 are separated from thearms 156. The actuation rod 50 is then moved proximally to pull the arms156 both into the housing 152.

[0168] For this configuration, an alignment mechanism can be providedsuch as the key way described above. But in the configuration shown, thenotch is circumferential. Thus, no alignment mechanism is needed, andany number of arms 156 extending from the actuating rod can be provided.

[0169] The suture catch 158 can be positioned over an introducer 168 ifdesired. If the proximal end of the introducer 168 is too large for thesuture catch 158 to fit over, the suture catch 158 could be made of aflexible material with a longitudinal slit over its entire lengthallowing it to be expanded to fit around the diameter of the introducer168. The arms 156 would be modified so that the needle points 154 extendbeyond the circumference of the introducer 168.

[0170]FIGS. 19 through 23 illustrate an alternate configuration of thesuture catch and suture clasp. A needle 400 is provided with a slottedopening 402 having a peg 404 extending from the top of the opening 402through a portion thereof. The peg 404 has a narrow and rounded frontpeg surface 406 with an identical radial location on the needle 400 asthe outer surface of the needle 400. The back peg surface 408 of theneedle 400 is relatively wide, rounded, and located toward the radialcenter of the needle 400. The peg sides 410 are flat and angled relativeto the walls 412 of the slotted opening 402. The slotted opening 402receives suture fitting 414 having a shaft 416 connected, preferably bycrimping, to the suture 40 and an enlarged termination 418 which ispreferably spherical.

[0171] The alternate suture fitting 420 of FIG. 22 has a half sphericaltermination 422 with rounded edges. The half spherical termination 422does not protrude beyond the diameter of the needle 400. This halfspherical termination 422 reduces the trauma to the vessel wall 22 whenthe needle 400 is retracted. The shaft in either configuration has alength short enough not to protrude from the diameter of the needle 400when the suture fitting is held by the needle 400. This also reducestrauma to the vessel wall 22 during retraction.

[0172] The suture fitting 414 is held by a modified suture clasp arm 424having an aperture 426 to receive the shaft 416 of the suture fitting414. The wall 428 of the aperture is slowly tapered so that the diameterdecreases as the aperture 426 moves inwardly in the arm 424. Thisfrustoconical shape provides a secure press fit with the suture fittingshaft 416. Other aperture shapes are possible so long as the press fitis secure and is of a force which can be overcome by the retraction ofthe arm 424. The shaft 416 of the suture fittings can also be tapered tobetter mate with the aperture 426.

[0173] When the suture clasp arm 424 is deployed, the termination 418,422 engages the peg 404 forcing it to one side allowing the termination418, 422 to slide against the peg 404 until the termination 418, 422 ispast the peg 404. When the termination 418, 422 slides past the peg 404,the peg 404 snaps toward its at rest central position thereby capturingthe termination 418, 422 and hence the suture 40. When the suture clasparm 424 is retracted, the press fit is overcome and the suture fitting414 is pulled from the arm 424. When the peg 404 snaps back into itscentral position, it tends to pull the suture fitting 414 away from thesuture clasp arm 424. This can be utilized to help overcome the pressfit. With the suture filling securely held, the needles are retracted,the suture fittings 414 cut from the suture 40, and the suture 40 tied.

[0174]FIGS. 24 and 25 illustrate another configuration of the suturecatch. A needle 450 is provided with a slot shaped opening 451 with aU-shaped raised portion 452 in the lower front of the slot 451. Theopening 451 also defines a suture fitting receiving area 454 at the topof the opening 451 for receiving a suture fitting 456 and a suturefitting catch area 458 in the lower back of the slot adjoining theraised portion 452. The suture fitting 456 has a spherical tip 459, andan arcuate neck 460 which tapers down to a cylindrical shaft 462. Thespherical tip 459 is sized to fit through the suture fitting receivingarea 454 but not through the U-shaped raised potion 452. Thus, theraised portion 452 holds the suture fitting 456 in the suture fittingcatch area 458. The raised portion 452 angles toward the back of theneedle 450, so that it becomes larger as it extends farther down theneedle 450.

[0175]FIGS. 26 and 27 show another configuration of the suture clasparms 464, which comprises an upwardly facing key hole shaped opening 466for holding the suture fitting 456. The opening 466 faces upwardly, thatis in the direction of needle retraction, to aid in the removal of thesuture fitting 456 from the suture clasp arm 464.

[0176] In operation, the suture catch is activated to penetrate thetissue to be sutured. The suture clasp arms 464 are deployed directingthe suture fitting 456 into the suture fitting receiving area 454. Asthe suture catch needle 450 is retracted, the neck 460 of the suturefitting 456 is engaged by the raised portion 452, and the angled surfaceof the raised portion 452 pulls the suture fitting 456 farther andfarther toward the back of the needle. Thus, the suture fitting 456 isbeing pulled out of the suture clasp arm 464 as the needle 450 isretracted. If the suture fitting 456 is not completely removed from thesuture clasp arm 464 when it contacts the bottom of the opening 451, itis snapped upwardly pass a neck 468 of the key hole opening 466 and outof the suture clasp arm 464.

[0177] The control of the distal and proximal translation of theactuating rod 50 is preferably performed by the three sector, armactuator assembly, generally designated 170, which is attached to thesuture introducer housing 24 (see FIG. 3). Each sector of the armactuator assembly 170 is substantially identical. FIGS. 28-31 show thatthe arm actuator handle is comprised of three pieces: a button 172, acylindrical guide 174, and a catch 176.

[0178] The button 172 comprises an actuation post 178 extendingcentrally from a closed end of a cylindrical body 180. The cylindricalbody 180 is sized to longitudinally slide in the guide 174. Three buttontabs 182 are spaced equally around the outer surface of the cylindricalbody at the end opposite the actuation post 178. Thus, there is onebutton tab 182 in each sector.

[0179] The catch 176 comprises three catch tabs 184 corresponding to thethree button tabs 182, a cylindrical body 186 which is sized to fitrotatably inside the cylindrical body 180 of the button 172, and acontrol ring 188 at an end of the cylindrical body 186 for engaging thethree button tabs 182. The control ring 188 is at the end of the catch176 corresponding to the end of the button 172 having the button tabs182, and the catch tabs 184 which rotate from sector to sector extendradially from the central ring 188.

[0180] The guide 174, which is attached at its proximal end to thehousing, has three channels 190 and three notches 192, and the guide 174is open at both ends; so that the button 172 protrudes from the proximalend, and the catch 176 can extend from the opposite (distal) end. Thereis one channel 190 in each sector with a notch 192 adjacent thereto. Thebutton tabs 182 and the catch tabs 184 are slidable within the channels190, each button tab 182 stays in the same channel 190 while each catchtabs 184 is rotated from a channel 190 to a notch 192 and to anotherchannel 190 during operation.

[0181] As indicated, the outer diameter of the button 172 is sized toslide inside the guide 174. Preferably, there is a button gap 194between the button 172 and the guide 174. The diameter of the controlring 188 is sized to rotate freely within the guide 174 with minimumclearance, and the catch cylindrical body 186 is sized to rotate andslide longitudinally inside the button cylindrical body 180 with minimumclearance. This leaves a relatively large catch gap 196 between thecatch cylindrical body 186 and the guide 174. Therefore, the length ofthe catch cylindrical body 186 is preferably long enough so that it isnever withdrawn from the button cylindrical body 180 during operation.

[0182] Because there is a button gap 194 between the button cylindricalbody 180 and the guide 174, the button tabs 182 have a thicknesssufficient to extend across the gap 194 and into the channels 190. Thus,the button tabs 182 also overlap the diameter of the control ring 188,so that the button tabs 182 can engage the control ring 188. The bottomsurface 195 of the button 172 is contoured to mate with the control ring188. The catch tabs 184 have a diameter and thickness so that they slidein the channels 190 and fit into the notches 192. Preferably, the outerdiameter of the guide 174 is the largest diameter thereby assuringadequate clearance for translation of the button 172 and catch tabs 184.

[0183] In FIGS. 28, 32, and 33, the catch 176 starts out in a proximalposition with the catch tabs 184 in the channels 190 as shown in FIG.32. A rotation spring 198 is held in compression between fixed plate200, which is attached to the housing 24, and the catch 176. Therotation spring 198 biases the catch 176 in the proximal direction,which corresponds to a retracted suture clasp arm position.

[0184] The physician presses down on the actuation post 178 of thebutton 172 causing the button tabs 182 to move distally pressing againstthe catch tabs 184 and control ring 188 thereby moving the catch tabs184 distally until the catch tabs 184 are beyond the distal edge 203 ofthe channels 190. At this point, the catch 176 rotates in the directionof arrow 202 in FIG. 32. The rotation is created by the rotation spring198 pushing a top angled surface 204 of the catch tab 184 against thebottom angled surface 206 of the button tabs 182. As the catch 176rotates, it also translates upwardly because of the angled surfaces.This prevents the catch 176 from rotating past the notch 192.

[0185] The physician then releases the actuation post 178 allowing therotation spring 198 to push the catch tabs 184 against the angled notchsurface 208 and rotate the catch tabs 184 until they contact thevertical notch stops 210 as illustrated in FIG. 28. In this rotationalposition, V-shaped depressions 212 on the control ring 188 are alignedwith the channels 190 of the guide 174. When the catch tabs 184 are inthe notches 192, the suture clasp arms 28, 30 are in a deployedposition.

[0186] To retract the needles 136, the physician again depresses theactuating post 178, so that the button tabs 182 engage the V-shapeddepressions 212 in the control ring 188 located between the catch tabs184. This pushes the catch tabs 184 below the bottom of the guide 174.The rotation spring 198 pushing upward on the guide 174 causes the slidesurface 214 of the V-shaped depression 212 to slide across the bottomsurface of the button tab 182 causing the catch tabs 184 to rotate andmove upwardly until they engage the angled bottom return surfaces 216 ofthe guide 174. After the physician releases the actuation post 178, therotation spring 198 continues to force the catch tab 184 to slide overthe return surface 216 until the catch tab 184 reaches the channel 190and the spring 198 forces the catch tab 184 upwardly into the channel190 thereby retracting the suture clasp arms 28, 30. As shown in FIG.33, a button spring 218 can be provided between the catch 176 and thebutton 172 to return the button 172 to an upward position after it isreleased. If the button spring 218 is used, the button tabs 182 contactthe tops of the channels 190 preventing the button 172 from coming offthe assembly.

[0187] The suture clasp arms 28, 30 are completely deployed when thecatch tab 184 is in the notch 192 against the notch stop 210. For theoperation of the actuator assembly, the catch tab 184 is pushed belowthis level several times. To prevent the arms 28, 30 from going past afully deployed position, a resilient member 220 is placed in theactuating rod 50. Once the suture clasp arms 28, 30 reach the fullydeployed position, their further motion is restricted as describedabove. As the catch tab 184 is pushed below the position correspondingto the fully deployed position, the resilient member 220 is compressedallowing the catch tab 184 to be moved the rest of the way below thebottom surface of the guide so that it can rotate to the next position.This prevents damage to the spreader 102, bending the actuating rod 50,and risk of injury to the vessel 16.

[0188] To allow the catch 176 to begin rotating after it clears thebottom of the channel 190 or the bottom of the vertical notch stop 210.The vertex 222 of the button tab 182 is not aligned with the bottom ofthe V-shaped depression 212 when the V-shaped depression 212 is alignedwith the channel 190. The vertex of the depressions 212 is positioned toa side of the vertex of the button tab 182 in the rotational direction,so that the catch 176 is allowed to rotate until it is underneath theshallow end of the return surface 216 of the guide 174. Similarly, whenthe catch tab 184 is inside the channel 190, the angled surfaces 224 ofthe control ring 188 corresponding to the catch tab 184 continue pastthe catch tabs 184 to again allow initial rotation of the catch 176until the catch tab 184 is beneath the shallow end of the notch surface.Thus, the catch tab 184 can rotate underneath the shallow end of thenotch 192 before the button tabs 182 contact the lowest point of thecontrol ring surfaces 224 and rotation is restricted. When the rotationis restricted, the actuation post 178 is released raising the button tab182 out of the way, and the catch 176 can complete its rotation.

[0189] The operation of the device is illustrated in sequence by FIGS.1, 2 and 34 through 36. After the medical procedure, the introducersheath 6 is left in place, and the suture introducer housing 24 isinserted into the introducer 6 and introduced into the artery 16 asshown in FIGS. 1A and 1B. The actuation post 178 is then depressed, asillustrated by arrow 240 in FIG. 35 to deploy the suture clasp arms 28,30 outwardly as illustrated by arrows 242 so that portions, preferablythe ends, are positioned on opposite sides of the opening 26 with thesuture 40 extending transverse to the flow of blood.

[0190] The introducer 6 is then removed, leaving the suture introducerhousing 24 with the suture clasp arms 28, 30 deployed inside the artery16. The opening 26 in the vessel 16 closes around the housing 24 afterthe introducer 6 is removed. In FIG. 38, the suture introducer housing24 is then oriented so that the arms 28, 30 extend transversely to theflow of blood through the vessel 16 which is illustrated by arrow 244.The suture catch assembly 36 is then inserted over the housing 24 andthe stop 144 is brought into contact with the top 146 of the housing 24as shown in FIG. 2. A physician depresses the activation ring 140 asillustrated by arrows 246 (FIG. 36) pushing the needles 136 through thevessel wall 22 and puncturing holes 248 in the vessel wall 22. Thesuture catch 38 catches the suture 40, and the suture catch assembly 36is pulled proximally as illustrated by arrows 250 (FIG. 37). The needles136 can be retracted inside the suture catch assembly 36 or leftdeployed. The suture 40 is cut from the suture catch 38 and pulled tightto remove it from the housing 24.

[0191] The suture clasp arms 28, 30 are retracted by depressing theactuation post 178 again, and the suture 40 is pulled tightsimultaneously with the housing 24 being pulled out of the artery 16.Alternatively, the length of the actuation post 178 is set to correspondwith the height of the depressed activation ring 140. Thus, when theactivation ring 140 is depressed, the actuation post 178 issimultaneously depressed for the second time thereby retracting the arms28, 30 simultaneously with pulling the suture catch assembly 36proximally.

[0192] With the suture catch 38 removed, the pattern of holes shown inFIGS. 38 and 39 is left. As stated above, the suture 40 closes theartery vessel opening 26 transverse to the flow of blood. This is themost efficient direction to close the opening 26. If additional sutureclasp arms are utilized, it is preferred that they make additional holesaround the circumference of the opening as shown in dashed lines in FIG.38, so that sutures again pull the opening 26 closed in a directiontransverse to the flow of blood.

[0193] The present invention could be similarly used to close a patentductus arteriosus, a patent foramen ovale, a heart defect, a puncturewound in the skin, and other tissues requiring suturing. For example,for closure of a heart septal defect such as an atrial septal defect(ASD), the suturing device may be used to close the defect opening byapproximating the tissue surrounding the defect opening. Access to suchheart septal defects can be provided by inserting a catheter includingthe suturing device into the right atrium via the inferior vena cava andthe femoral artery. Alternatively, access to such heart septal defectscan be provided by inserting the catheter including the suturing deviceinto the right atrium via the superior vena cava and the subclavian veinor internal jugular vein. Once the suture clasp arms 28, 30 are deployedand the suture 40 is positioned on the left-atrial side of the ASD, theneedles 136 can be extended to puncture through the tissue of the septalwall surrounding the ASD to engage the suture 40 with the suture catches38. Retracting the needles 136 then pulls the suture 40 through theseptal wall, and further tension applied to the suture 40 closes the ASDby approximating the surrounding tissue of the septal wall. Similarprocedures can be used to repair other septal defects such as patentforamen ovales, ventricle septal defects (VSD), endocardial cushiondefects, or septal defects existing in conjunction with Tetralogy ofFallot. As discussed below in conjunction with FIGS. 82-84, where thesize of the septal defect is so large that approximation of the tissuesurrounding the septal defect would result in excessive distortion ofthe cardiac tissue, the suturing device may be used in conjunction witha patch.

[0194] An alternate configuration of the suturing device is shown inFIG. 40. The device comprises a pair of suture clasp arms 270 attachedto the end of an actuating rod 272 in accordance with one of the abovedescribed configurations. The actuating rod extends through a needlecover 274 and slidably through a needle actuator 276 to a suture armdeployment handle 278. Near the deployment handle 278 the actuating rod272 has, a severable junction 279. The junction 279 is threaded or snapfit allowing the actuating rod 272 to be quickly separated and joinedthereby quickly removing or attaching the handle 278 from the remainderof the device. The actuating rod 272 can, in the alternative, have ajunction where it enters the needle cover 274.

[0195] Needles 280 are held near their distal ends by a needle guide 282and pass through a stop 284 that limits the deployment distance of theneedles 280. The needles 280 fixably attaching to the needle actuator276. A spring 286 is interposed between the stop 284 and the needleactuator 276 to bias the needles 280 in a retracted position. A secondstop 288 is fixed to the actuating rod 272 on the opposite side of theneedle actuator 276 to prevent the needles 280 from being pulled out ofthe needle guide 282.

[0196] The actuating rod 272 terminates at a thumb ring 290 separatedfrom the distal end of the suture arm deployment handle 278 by a thumbring spring 292 which biases the thumb ring 290 in a proximal positionwhich corresponds to a retracted position of the suture clasp 270. Thehandle 278 also comprises two finger rings 294, 296 on opposite sides ofthe handle allowing a physician to smoothly overcome the force of thethumb ring spring 292.

[0197] In operation, the distal portion of the device, from the needlecover 274 to the suture clasp arms 270, is inserted into the introducer6 with the handle 278 detached. The introducer 6 is removed and thehandle 278 is attached to the device by connecting the actuating rod272. The thumb ring 290 is pushed distally to deploy the suture clasparms 270. A clip 298 hooks onto a clip ring 300 to lock the suture clasparms 270 in the deployed position.

[0198] The actuating rod 272 includes a resilient member 302 (shownschematically), which functions, as described in the previousconfigurations, to prevent the suture clasp arms 270 from moving pasttheir deployed position. The resilient member 302 can simply comprise aspring, or a spring housing can be provided on one part of the actuationrod 272 to receive a spring and a slidable plunger therein. The plunger,which is provided on the opposite part, slides to a maximum distalposition defined by the spring housing and is biased in that position bythe spring. When the suture clasp arms 270 reach a deployed position,the plunger is then forced into the spring housing, compressing thespring and allowing the upper portion of the actuation rod 272 to traveldistally without forcing the suture clasp arms 270 past a deployedposition or bending the actuation rod 272. A thumb ring stop 304prevents the thumb ring 290 from being pushed beyond a point for whichthe resilient member 302 could compensate.

[0199] With the suture clasp arms 270 deployed, the physician grasps theneedle actuator 276, which has a central curved indented surface 306 tomake it easy to grasp, and pushes the needle actuator 276 distally. Theneedles 280 are pushed into the vessel 16 and catch the suture 40 asdescribed in one of the above configurations. The stop 284 prevents theneedles 280 from penetrating too far and damaging the vessel 16. Thespring 286 pushes the needles 280 back to a retracted position when theneedle actuator 276 is released.

[0200] With the suture 40 held by the needles 280, the thumb ring 290 ispushed in a direction transverse to the length of the actuating rod andaway from the clip 298 as illustrated by arrow 308 to release the clip298 and retract the suture clasp arms 270. The entire device isretracted, the suture 40 cut from the needles 280, and the suture 40tied to close the opening 26. Because the handle 278 is detachable, thehandle 278 could be used in conjunction with the above describedconfigurations. In such a case, the arm actuator assembly would beremoved, and the actuating rod 50 would extend through the top of thehousing 24. The end of the actuating rod 50 would be modified to connectto the handle 278.

[0201] Embodiments of FIGS. 1C-1D and 41-50

[0202] In the embodiments described above, the suture introducer housing24 and the suture catch assembly 36 consist of two separate pieces,wherein the suture catch assembly 36 operatively fits around the sutureintroducer housing 24. As described above with reference to FIGS. 1A-1B,in these embodiments, the physician fully removes the original CSI 6before inserting the suture catch assembly 36 to penetrate the bloodvessel wall and catch the ends of a suture. The removal of the CSI 6 andthe introduction of the suture catch assembly 36 may disturb the flesh14 or enlarge the incision 20 and add to the complexity of theprocedure.

[0203] The embodiments illustrated in FIGS. 1C-1D and 41-50, however, donot require the full removal of the original CSI 6 (used for theoriginal percutaneous approach procedure, such as anangioplasty/angiography procedure) in order for the device to catch theends of a suture. Rather, as depicted in FIG. 41, the distal portion ofthe device 520 passes through the CSI 6 and the flesh 14 of thepatient's thigh 12 with minimal disturbance to the flesh 14, and throughthe second incision 26 into the femoral artery 16. Any disturbance tothe flesh 14 is significantly reduced because the CSI 6 is not removedand a suture catch assembly is not slid down over a suture introducerhousing through the flesh 14, as in the embodiments described above withreference to FIGS. 1A-1B and 240.

[0204] FIGS. 41-48 illustrate the device 520 depicted in FIGS. 1C-1Dwhere the suture introducer housing and the suture catch assembly areintegrated into a single suture insertion and retraction device 520.This suturing device 520 may comprise a one-piece suture insertion andretraction housing 515 as shown in FIG. 48, or may comprise a sutureintroducer head 522 attached to the distal end of a hollow elongatedbody 514 as shown in FIG. 41.

[0205] With reference to FIG. 41, the suture introducer head 522 and thehollow body 514 are narrower in diameter than the configurationsillustrated in FIGS. 1A-1B and 2-40 because the suture clasp member 500and the needles 546 reside in the same longitudinal space. In otherwords, the needles 546 share the same housing as the suture clasp member500 (while they are all in their retracted state), but are higher up(proximally) in the suturing device 520 than the suture clasp member500. An important feature of this embodiment is that it uses flexibleneedles 546 which bend outward, away from the axis of the device 520,when in the extended position (as shown in FIG. 47).

[0206] The dimensions of the suturing device 520 may vary according tothe suture site and the biological tissue intended to be sutured. In oneconfiguration, the diameter of the suture introducer head 522 is about0.105 inches, and the diameter of the hollow elongated body 514 is about0.098 inches.

[0207] As shown in FIGS. 42, 46 and 47, the suture introducer head 522has two needle ports or apertures 510 formed therein (one per needle546) proximal to the suture clasp arms 524. Each needle port includes aneedle guiding portion 512 (“needle guide”), in the form of an outwardlycurved groove or channel, which guides the corresponding needle 546along a particular path. The needle guides 512 may be formed within thesuture introducer head 522 (as shown in FIG. 41) as part of a mold, ormay be separate pieces (not shown) that are inserted into the sutureintroducer head 522 during manufacture.

[0208] Another advantage of the embodiments illustrated in FIGS. 41-48is the required size of the initial incision 20 into the patient's bodyand the diameter of the introducer sheath 6 used to insert the device520 may be reduced. The size of the suture device 520 may vary dependingon the application and the size of the vessel incision 26.

[0209]FIG. 46 shows a preferred configuration of the hollow elongatedbody 514 with five lumens. Two of the lumens 516 are used to house theneedles 546 (FIG. 41). Another lumen 530 is used to house the actuatingrod 50. Another lumen 532 is used to hold the length of the suture 40 toprevent the suture 40 from becoming tangled. Alternatively, the suture40 may be stored in the actuating rod lumen or in a hole drilled intothe suture clasp arm 500.

[0210] The fifth lumen 534 is preferably used for ‘bleed back,’ whichlets the physician determine whether the distal end 504 of the sutureintroducer head 522 is still positioned in the artery 16 after thephysician removes the catheter sheath introducer (CSI) 6. Bleed back isaccomplished by the hole 540 (FIG. 45) at the distal end 504 of thesuture introducer head 522, the suture clasp arm apertures 508 and anyother openings in the suture introducer head 522. The direction of bloodflow for bleed back is shown by the dashed arrows in FIGS. 41 and 48. Ifthe distal end 504 of the introducer head 522 is still in the artery 16,the blood pressure measured by the blood coming up into the hole 540will be much greater than if the distal end 504 is not in the artery 16.In one embodiment, the bleed back lumen 534 extends to a port (notshown) at a proximal portion of the device, and the physician canobserve the blood pressure through bleed back lumen 534 by monitoringblood flow from the port. For example, the bleed back lumen may beattached to a balloon which inflates when the distal portion 504 of thesuture introducer head 522 is within the blood vessel 16. In anotherembodiment, a pressure sensor is associated with the blood flow lumen534 to provide the physician with a numeric reading. Alternatively, thefifth lumen 534 may be used to inject medication or for diagnosticpurposes.

[0211] In a preferred embodiment, two thin stripes 538 (only one shownin FIG. 46) are marked on the exterior of the elongated body 514 whichdenote the circumferential location of the two needles 546. Thesestripes extend along a portion of the elongated body 514 which isoutside the patient's body. These stripes help the physician to alignthe needles 546 with the axis of the blood vessel 16, so that the needleincisions 248 (FIG. 47) will be longitudinally aligned. As describedabove for FIG. 38, the suture 40 closes the artery vessel opening 26transverse to the flow of blood. This is the most efficient direction toclose the opening 26. Proper insertion of the needles 546 reduces therisk of damage to the vessel walls 22, 506. Alternatively, there may beonly one stripe to denote the circumferential location of one of the twoneedles 546. The physician will know the circumferential location of theother needle 546 because the needles 546 are 180 degrees apart.

[0212] As illustrated in FIG. 46, the exterior surface of the elongatedbody 514 includes a marker 539 which denotes the proximal position towhich the CSI 6 should be partially withdrawn (after the distal portionof the suturing device 520 has been inserted into the blood vessel 16)to expose the needle apertures 510. The partial withdrawal of the CSI 6is described below. The marker 539 is shown as a visual marker, but mayadditionally or alternatively be in the form of a ridge, groove, orother physical structure which interacts with a corresponding structureof the CSI to allow the physician to position the CSI using the sense offeel. For example, the CSI 6 and elongated body 514 could be configuredto releasably engage or interlock with one another when the CSI reachesthe proper position along the body 514. A specially formed CSI whichincludes such an interlocking structure is included within the scope ofthe invention. One or more additional longitudinal markers (not shown)could be provided along the body 514, distal to marker 539, to indicateother relative positions of the CSI and the body 514, such as theposition at which the retractable arms 524 are exposed outside the CSI.

[0213] As illustrated in FIGS. 41-43, the device 520 includes a single,resilient suture clasp member 500 attached to the actuating rod 50. Thisresilient suture clasp member 500 is preferably of a unitaryconstruction as shown. The suture clasp member 500 comprises a center orhinge portion 542 and two suture clasp arms 524 (one for each needle546). Each suture clasp arm 524 has a suture clasp 544 at the endthereof.

[0214] The hinge portion 542 of the suture clasp member 500 acts as a“living hinge” because it has a memory which causes the member 500 toreturn to a partially open, unretracted position (FIG. 42) when a force(applied via rod 50) is released. This can be seen in FIGS. 41 and 42.In FIG. 42, the suture clasp member 500 is deployed in the artery 16 inits predisposed (relaxed or natural) position. In FIG. 41, the sutureclasp member 500 is retracted into the suture introducer head 522 in itscompressed (stressed or tensed) position. The arms 524 are moved to theretracted position by applying a distal force to the actuator rod 50,which causes the arms to contact deflection surfaces 518 (FIG. 42).

[0215] This suture clasp member 500 is preferably composed of aresilient shape memory material such as NITENOL. The suture clasp member500 may alternatively be composed of another material with spring-likecharacteristics, such as plastic, spring steel, stainless steel or anyvariations thereof. Further, the suture clasp member 500 could becomposed of two arms that are hingedly connected to the actuating rod 50without the use of a resilient hinge, as shown in FIGS. 43C and 43D anddescribed below.

[0216] The living hinge configuration is easily adaptable to havingthree arms spaced at 120 degrees or four arms (as in FIGS. 58 and 59)spaced at ninety degrees. If there are three arms, then there arepreferably 3 needles 546 and six lumens in the elongated body 514. Thus,other configurations and numbers of arms can be incorporated into thedevice to accomplish the specific needs of the application.

[0217] The needles 546 are flexible and preferably made from a materialwith shape memory, such as SUPERFLEX NITENOL. Alternatively, the needles546 may be composed of spring steel, surgical stainless steel or anyvariation thereof The diameter of the needles 546 is preferably about0.019 inches, but needles with other diameters may be used in accordancewith the present invention.

[0218] When the needles 546 are advanced distally and come in contactwith the needle insertion guides 512, the needle insertion guides causethe needles 546 to bend radially outward. The needles 546 alsopreferably further bend slightly (radially outward) when they come incontact with the angled surfaces 545 of the suture clasp arms 524, asshown in FIG. 47. When the needles 546 are retracted into the needlelumens 516, they resume a straight configuration as a result of theirresiliency. Although the embodiment of FIGS. 41-48 preferably usesflexible needles which bend during deployment, it is contemplated thatnon-bending needled, which may be either straight or curved, couldalternatively be used.

[0219] As illustrated by the cut-away views of FIGS. 43A and 43B, theactuating rod 50 attaches to the resilient suture clasp member 500 by apivot pin 502. The actuating rod 50 in this configuration preferablycomprises a single shaft (as shown), but may comprise a plurality ofshafts in other configurations.

[0220]FIG. 43C is a perspective view of a non-living hinge embodiment ora two-piece suture clasp member 501. FIG. 43D is a cross-sectional viewof the two-piece suture clasp member 501 and a ramp or spreader 523within the suture introducer head 522. Alternatively, the hinge portionof the suture clasp arms 525, 525′ with suture clasps 544 may be similarto a hinge portion shown in FIG. 53, which is described below. Thespreader 523 may be a separate piece attached within the sutureintroducer head 522. Alternatively, the spreader and suture introducerhead 522 may comprise a single molded piece.

[0221] The length of the suture clasp arm 525 is preferably about 0.174inches. The length of both of the suture clasp arms 525, 525′ togetherin their fully extended position (deployed with both arms parallel toeach other) is preferably about 0.288 inches. In other configurations ofthe suture clasp arms 525, 525′, the dimensions may vary.

[0222] In FIG. 43D, when the actuating rod 50 pulls the two-piece sutureclasp member 501 proximally (while the suture clasp member 501 is in itsretracted position), the distal edges of the spreader 523 come incontact with the tips of the suture clasp arms 525, 525′. The spreader523 causes the two suture clasps arms 525, 525′ to open radially outwardrelative to the actuating rod 50. In a preferred method of operation,the actuating rod 50 continues to pull the suture clasp member 501proximally until the center of the suture clasp member 501 fits into thecenter of the spreader 523. To retract the suture clasp arms 525, 525′into the suture clasp member's retracted position, the actuating rod 50is advanced distally, and the interior edges 518 of introducer head 522come in contact with the suture clasp arms 525, 525.′ The interior edges518 of introducer head 522 cause the two suture clasp arms 525, 525′ toretract radially inward relative to the actuating rod 50. The generaluse and operation of the two-piece suture clasp member 501 is similar tothe use and operation of the suture clasp member 500 shown in FIG. 43A,as described below.

[0223] The proximal portion of the suturing device 520 preferablyincludes a handle which allows the physician to externally operate thesuture clasp arms 524 and the needles 546 inside the blood vessel 16.This handle preferably has three actions: a first action in which theactuating rod 50 applies a proximal force to the hinge portion 542 todeploy and maintain the arms 524 in a fully outward position (FIG. 47);a second action to advance the needles 546 distally (FIG. 47) and pullthe needles 546 back proximally using one or more springs; and a thirdaction in which the actuating rod 50 applies a distal force to the hingeportion 542 to retract the arms 524 (FIG. 41 or 48).

[0224] Alternatively, the handle may be a 2-action handle in which oneof the two actions is a combination of two of the three actionsdescribed above for the 3-action handle. For example, in a first action,the actuating rod 50 applies a proximal force to the hinge portion 542to deploy and maintain the suture clasp arms 524 in a fully extendedstate of FIG. 47. With the arms 524 in this fully extended position, theneedles 546 automatically advance distally (FIG. 47) and retractproximally to capture the looped ends of the suture 40. In a secondaction for this 2-action handle, the actuating rod 50 applies a distalforce to the hinge portion 542 to retract the arms 524 (FIG. 41 or 48).This 2-action handle is suited for physicians with more experience inoperating this suture device 520. It will be apparent to one of ordinaryskill in the art that a 1-action handle or a 4-action handle (insertingand withdrawing the needles 546 as two separate actions) could be used,or that separate handles or triggers could be provided for differentactions.

[0225]FIG. 49 is a cross-sectional view of one embodiment of a handle550 operatively attached to the proximal end of the hollow elongatedbody 514 of FIG. 41 or the single suture insertion and retractionhousing 515 of FIG. 48 or the device of FIG. 52A. FIG. 50 is aperspective view of the handle 550. FIG. 57 is a perspective view of thehandle 550 of FIG. 49. The handle 550 comprises an actuating rodaperture 551, a main housing 552, a pair of finger grips 554, a sutureclasp arm piston 556 with a locking groove 576, a needle piston 560 withat least one raised key portion 562, a releasor 568 with a lockingstopper 572, a pivot pin 570, a releasor support 574, a compressionspring (not shown) operatively positioned in a spring recess 578 betweenthe suture clasp arm piston 556 and the needle piston 560, a needlepiston support cylinder 580 with at least one grooved recess 564 andneedle clamps 584.

[0226] In one configuration, the housing 552 is attached to or is acontinuation of the hollow elongated body 514 of FIG. 41 or the singlesuture insertion and retraction housing 515 of FIG. 48. In anotherconfiguration, the housing 552 is separate from the hollow elongatedbody 514 or single suture insertion and retraction housing 515. In thisconfiguration, the actuating rod 50 connects the housing 552 with thehollow elongated body 514 or single suture insertion and retractionhousing 515.

[0227] A proximal portion of the actuating rod 50 (FIGS. 41 and 48)slides through the actuating rod aperture 551 at the distal end of thehousing 552. The proximal end of the actuating rod 50 is attached to thedistal end 558 of the suture clasp arm piston 556, which is slidablyreceived within the main housing 552. A compression spring (not shown)resides in the spring recess 578 of the housing 552 between the sutureclasp arm piston 556 and the needle piston 560 and simultaneously exertstwo forces: a distal force on the suture clasp arm piston 556; and aproximal force on the needle piston 560.

[0228] The needle clamps 584 of the needle piston 560 hold the proximalends of the needles 546. The needle piston 560 is slidably receivedwithin a distal portion of the housing 552. The needle piston supportcylinder 580 is attached to the housing 552 and preferably does not moverelative to the housing 552.

[0229] The releasor 568 pivots radially inward and outward on the pivotpin 570. The releasor support 574 exerts a radially outward force on thereleasor 568. This force causes the releasor 568 to pivot and thelocking stopper 572 to fall into the locking groove 576 of the sutureclasp arm piston 556 when the locking groove 576 is aligned to receivethe locking stopper 572. The releasor support 574 is preferably made ofa resilient shape memory material such as NITENOL. The releasor support574 may alternatively be composed of another material with spring-likecharacteristics, such as plastic, spring steel, stainless steel orvariations thereof. Other embodiments of the handle are described belowwith reference to FIGS. 57, 60 and 61.

[0230] The use and operation of the device 520 and the handle 550 willnow be described with reference to FIGS. 1C-1D and 41-50. In operation,with the CSI extending into the patient's artery 16, the physicianinserts the suture introducer head 522 through a catheter sheathintroducer (CSI) 6 and into the artery 16 (FIGS. 1C-1D). The CSI 6 isthen partially withdrawn along the body 514 of the suturing device 520to remove the CSI 6 from the artery 16 and expose the needle apertures510, as shown in FIG. 41. There are one or more markings 539 (FIG. 46)on the exterior surface of the elongated body 514 which indicate how farthe physician should withdraw the CSI 6 to expose the needle apertures510.

[0231] The distal end 504 of the introducer head 522 has a smooth,rounded surface to prevent injury to the opposite vessel wall 506 wheninserting the introducer head 522. In addition, the blood flow in theartery 16 is uninterrupted because the introducer head 522 does notocclude the artery 16. The physician may use the aperture 540 at thedistal end of the suture introducer head 522 and the bleed back lumen534 to determine when the distal end 504 of the suture introducer head522 is in the artery 16.

[0232] While the introducer head 522 is inserted into the artery 16 inFIG. 41, the actuating rod 50 holds the resilient suture clasp member500 in its compressed position within the introducer head 522. Theactuating rod 50 applies a downward force while the interior edges 518of the introducer head 522 apply an inward force on the two suture clasparms 524. The combination of these two forces cause the hinge portion542 of suture clasp member 500 between the two arms 524 to elasticallydeform or compress. The suture clasps 544 hold the looped ends of asuture 40 in the angled slot of the suture clasps 544 as shown in FIGS.41-43A. The looped ends of the suture 40 are held securely by the sutureclasps but are positioned for easy removal by the suture catches 38 ofthe needles 546.

[0233] When the distal portion of the device 520 (FIGS. 41 and 48) isproperly positioned in the blood vessel 16, the physician may deploy thesuture clasp arms 524 (FIG. 42) by pulling the finger grips 554 in aproximal direction relative to the housing 552 (FIG. 50). A physicianmay pull the suture clasp arm piston 556 proximally by placing thephysician's index and middle finger around the finger grips 554 andpushing on the proximal end 582 of the housing 552. This action issimilar to operating a standard syringe. This motion compresses thespring (not shown) in the spring recess 578 of the handle 550 in aproximal direction. As the suture clasp arm piston 556 moves proximally,the actuating rod 50 moves in a proximal direction relative to theelongated body 514 or housing 515. This is shown by the arrows in FIG.42. This motion causes the suture clasp member 500 to deploy or open toits predisposed or natural position as shown in FIG. 42. The sutureclasp arms 524 deploy out of the introducer head 522 into the bloodvessel 16 through two suture clasp arm apertures 508 (FIG. 42), one oneither side of the introducer head 522.

[0234] When the physician pulls the suture clasp arm piston 556 acertain proximal distance relative to the housing 552, the lockingstopper 572 at the distal end of the releasor 568 moves radially inwardand falls into the locking groove 576 of the piston 556. The lockingstopper 572, in combination with the locking groove 576, prevents thesuture clasp arm piston 556 from advancing distally. The force of thespring in recess 578 prevents the suture clasp arm piston 556 frommoving proximally. The locking of the suture clasp arm piston 556stabilizes the suture clasp arms 524 in a locked position before theneedles 546 are advanced distally.

[0235] In this locked position, the suture clasp arms 524 preferablyhave reached their fully extended position, as shown in FIG. 47. In thefully extended position, the actuating rod 50 (attached to the sutureclasp arm piston 556) has pulled the resilient suture clasp member 500up, and the proximal inside edges 536 of the aperture 508 have come incontact with the arms 524 of the suture clasp member 500. This is shownin FIG. 47. The pulling of the actuating rod 50 and the stationaryinside edges 536 of the apertures 508 cause the arms 524 to bendbackward until the arms 524 are longitudinally aligned with each other,as shown in FIG. 47. Thus, the resilient suture clasp member 500 isdeformed from its natural configuration again, but this time in anextended position instead of a compressed position. In this extendedposition, the physician may move the suturing device 520 proximally sothat the arms 524 touch the interior of the vessel wall 22 while theneedles 546 advance distally and capture the ends of the suture 40 fromthe suture clasps 544.

[0236] Next, the physician twists the needle piston 560 clockwise orcounter-clockwise until the raised key portion 562 of the needle piston560 matches the grooved recess 564 of the needle piston support cylinder580. The grooved recess 564 of the needle piston support cylinder 580allows the raised key portion 562 of the needle piston 560 to advancedistally. Otherwise, the needle piston 560 may not be advanced distallyif the raised key portion 562 does not match the grooved access 564. Theneedle piston support cylinder 580 and the raised key portion 562 of theneedle piston 560 prevent the needles 546 from advancing distallyprematurely or improperly. Premature or improper insertion of theneedles may cause damage to the patient's surrounding tissue 14 (FIGS.1B and 1D) or the blood vessel 16.

[0237] When the raised key portion 562 of the needle piston 560 matchesthe grooved recess 564 of the needle piston support cylinder 580, thephysician may advance the proximal end of the needle piston 560 (withthe physician's thumb or palm) in a distal direction relative to theproximal end 582 of the housing 552. This motion compresses the springin the spring recess 578 in a distal direction. When the needle piston560 advances distally, the needles 546 and the suture catches 38 on theneedles (FIG. 47) also advance distally.

[0238] The paths taken by the needles 546 are illustrated in FIG. 47.The needles 546 slide along the needle housings 516 (or needle lumens)and out of the suture device 520 through needle apertures 510. When theneedles 546 come in contact with the needle insertion guides 512, theneedles 546 begin to bend radially outward. As the needles 546 exit,they are guided at a radially outward, acute angle away from theactuating rod 50 by the needle insertion guides 512. The angle of theneedle deflection is preferably 13.2 degrees. Deflection angles in theranges of 10 to 15 degrees and 5 to 20 degrees are also contemplated.

[0239] The needles 546 then penetrate the vessel wall 22 at an angle bycreating incisions 248 on either side of the main vessel incision 26.The needles 546 also preferably bend slightly (radially outward) whenthey come in contact with the suture clasp arms 524. The combination ofthe suture clasps 544 and the suture catches 38 on the needles 546creates a lock on the looped ends of the suture 40, such that the sutureends will not fall off while the needle 546 engages the suture claspmember 500.

[0240] The physician advances the needle piston 560 distally until theresistance of the compression spring prevents the needle piston 560 fromadvancing any further distally. In this position, the needles 546 aresufficiently advanced in the blood vessel 16 such that when the needles546 are pulled back proximally, the suture catches 38 on the needles 546will catch the looped ends of the suture 40 from the suture clasps 544.As shown in FIG. 47, the clasp arms 524 hold the suture loops away fromthe suture introducer head 522, so that the needles 546 pierce thevessel 22 and catch the suture loops outside the perimeter of the sutureintroducer head 522.

[0241] After the physician advances the needle piston 560 to itsfarthest distal position, the physician releases the needle piston 560.The compressed spring causes the needle piston 560 to immediately springback proximally. This motion causes the distal portion of the needles546 to immediately spring back proximally into the needle housing 516with the looped ends of the suture 40 attached to the suture catches 38.

[0242] The suture catches 38 on the needles 546 catch the suture loopsheld by the suture clasps 544 and pull the ends of the suture 40 upthrough the punctured holes 248 when the needles 546 are retractedproximally. When the needles 546 are retracted into the needle lumens516, they resume a straight configuration. As the needles 546 retract, asegment of the suture 40 is released (as a result of the tension causedby the retracting needles 546) through an aperture 540 at the distal end504 of the suture introducer head 522 and into the artery 16.

[0243] To retract the suture clasp arms 524 (FIGS. 41 and 48), thephysician presses the proximal portion of the releasor 568 in a radiallyinward direction. This motion causes the releasor 568 to pivot. Thelocking stopper 572 moves radially outward and releases the lockinggroove 576. The force of the compressed spring causes the suture clasparm piston 556 and the actuating rod 50 to advance distally. Togetherwith the proximal interior edges 518 of the introducer head 522, thedownward force of the actuating rod 50 causes the resilient suture claspmember 500 to retract into its compressed position. As shown in FIGS. 44and 45, the suture clasp arms 524 retract into respective apertures orgrooves 508 on the exterior surface of the introducer head 522. In thisretracted state, the arms 524 are substantially parallel with theelongated body 514. As FIG. 44 illustrates, the exterior surfaces of thearms 524 are flush with the exterior surface of the introducer head 522.This reduces the likelihood that the arms 524 will catch on the vesselwall 22 or flesh 14 during withdrawal. The device 520 is now ready forremoval from the blood vessel 16.

[0244] The physician withdraws the device 520 out of the blood vessel 16and out of the flesh 14 of the patient's thigh 12. After the device 520is withdrawn (and with the CSI 6 still in the flesh 14), the physicianpulls the ends of the suture 40 and closes the main vessel incision 26.The physician then ties at least one knot with the ends of the suture 40and slides or pushes the knot(s) down through the CSI 6 to the vesselincision 26. Alternatively, the physician may fasten a small, circularor flat stainless steel clip (not shown) to the ends of the suture 40and slide the clip down through the CSI 6 to the vessel opening 26 toclose the opening 26. The physician then cuts the unused ends (extralength) of the suture 40 and removes the cut portions. The physicianthen removes the CSI 6 from the patient's thigh 12.

[0245] Some of the advantages of the suturing device 520 shown in FIGS.41-48 will now be described in greater detail. First, the radialdeployment of the suture clasp arms 524 (FIGS. 41-42 and 47) from thesides of the suturing device's body, instead of deployment from thedistal tip, provides an advantage over other embodiments. The device 520shown in FIGS. 41-48 deploys its suture clasp arms 524 in a radialdirection without extending beyond the distal end 504 of the device 520.Thus, this device 520 reduces the likelihood that the suture clasp arms524 will contact and damage the inner vessel wall 506 opposite theincision 26.

[0246] Second, the locked position of the suture clasp arms 524 (asdescribed above with reference to FIG. 47) provides a stable base orfoundation for holding the looped ends of the suture 40 while theneedles 546 come in contact with the suture clasp arms 524 and capturethe suture 40. The suture clasp arms 524 are locked in the lockedposition by the proximal force of the actuating rod 50, the stationaryinside edges 536 of the apertures 508 and the protrusions 528 at the‘elbow’ end of each arm 524 (FIG. 47). Specifically, when the sutureclasp arms 524 become substantially parallel with each other (i.e., eacharm 524 is at an angle of approximately 90 degrees from the actuatingrod 50), the protrusions 528 at the ‘elbow’ end of each arm 524 comeinto contact with each other and prevent the arms 524 from bending anyfurther than the configuration shown in FIG. 47. The suture clasp member500 cannot open any farther, even when the needles 546 are inserteddistally and come in contact with the suture clasp arms 524. Theprotrusions 528 prevent the suture clasp member 500 from movingunintentionally (opening any farther) when the needles 546 come incontact with the suture clasp arms 524. This reduces the risk of thelooped ends of the suture 40 being accidentally displaced from thesuture clasps 544 when the needles 546 engage the suture clasps 544.Thus, the combination of forces asserted by the actuating rod 50, theproximal inside edges 536 of the aperture 508 and the two protrusions528 sustain the suture clasp arms 524 in a rigid, locked position tofacilitate the proper removal of the suture looped ends from the sutureclasps 544.

[0247] Third, the shape and position of the angled slits of the sutureclasps 544 in FIGS. 41-48 provide another advantage. The slits of thesuture clasps 544 in FIGS. 41-48 are angled in a proximal, radiallyinward direction. Thus, the face of the looped ends of the suture 40face in a proximal, radially inward direction. In this configuration,there is less chance of the looped ends of the suture 40 falling off thesuture clasps 544 improperly or prematurely. When the needles 546 engagethe suture clasp arms 524, the only direction the looped ends may moveis in a proximal, radially inward direction, which is in the oppositedirection of the inserted needles 546. When the needles 546 retractproximally (as shown in FIG. 47), the looped ends reliably fall into thesuture catches 38 of the needles 546. It is the proximal movement of theneedles 546 in the embodiments in FIGS. 41-48 which causes the suturecatches 38 on the needles 546 to catch the looped ends of the suture 40.This configuration does not rely on a radially outward tension in thelooped ends to fasten the looped ends onto the suture catches 38 whenthe needles 546 are inserted distally.

[0248] In the various embodiments described with reference to FIGS.1C-1D and 41-48, retractable suture clasp arms are used to hold thesuture 40 beyond the outer circumference of the tubular housing (andthus beyond the boundaries of the incision 26), and flexible needles 546are used to capture the held suture 40 outside the outer circumference.In other implementations (not shown), the suture clasp assembly may bein the form of a fixed (non-moving) member which holds the suture nearor within the circumference of the housing. In such implementations,curved needles may be used which pierce the vessel wall outside thecircumference of the housing and then “curve in” to capture the suture.The curved needles may then be withdrawn to pull the ends of the sutureout of the vessel wall.

[0249]FIG. 51 is a cross-sectional view of another embodiment of ahandle 600 attached to the proximal end of the hollow elongated body 514of FIG. 41 or the single suture insertion and retraction housing 515 ofFIG. 48 or the device of FIG. 52A. The handle 600 of FIG. 51 comprises ahousing 602 with a spring recess 622, a pair of external finger grips604 (only one shown in FIG. 51), a suture clasp arm piston 606 with alocking groove 608, a releasor 612 with a locking head 610 and a needlepiston stopper 618, a pivot pin 614, a needle piston 620 with needleclamps 616 and a spring 624.

[0250] The handle 600 also includes a second spring (not shown) whichbiases the releasor 612 toward a position in which the locking head 610is engaged with the groove 608. Similar to the handle 550 shown in FIG.50, the finger grips 604 extend outside the housing 602 to allow aphysician to move the piston 606 relative to the housing 602. Theneedles 546 in FIG. 51 are attached to the needle clamps 616, which isattached to the needle piston 620. The actuating rod 50 (FIG. 41) isattached to the suture clasp arm piston 606 in FIG. 51.

[0251] The general operation of the handle 600 shown in FIG. 51 issimilar to the operation of the handle 550 shown in FIGS. 49-50. In FIG.51, the needle piston stopper 618 prevents the needle piston 620 fromdistally advancing prematurely or improperly. This function is similarto the function of the raised key portion 562 and grooved recess 564 ofthe handle 550 shown in FIGS. 49-50. In FIG. 51, the physician advancesthe suture clasp arm piston 606 proximally against the biasing force ofthe spring 614 (by pulling the finger grips 604 proximally) to deploythe suture clasp arms 524 (FIG. 42) until the locking head 610 of thereleasor 612 moves radially inward and falls into the locking groove608. At this point, the clasp arms 524 are in the fully deployed or openposition as in FIG. 47. This motion causes the proximal portion of thereleasor 612 to advance radially outward until the needle piston stopper618 is no longer blocking the needle piston 620. At this time, thephysician may advance the needle piston 620 distally into the recess 622to cause the needles 546 to advance distally and capture the suture 40.When the physician releases the needle piston 620, the spring 614 movesthe needle piston proximally to the outward position, causing theneedles 546 to retract with the suture 40. Finally, the physicianpresses the external lever portion of the releasor 612 to release thesuture clasp arm piston 606; this causes the suture clasp arms 524 toreturn to the retracted position, so that the device can be withdrawnfrom the artery 16.

[0252] One of ordinary skill in the art will appreciate that there aremany possible configurations of this handle attached to the proximal endof the device 520. In one configuration (not shown), there are at leasttwo springs or sets of springs (not shown), instead of the singlecompression spring as used by the handle 550 in FIGS. 49-50 and thehandle 600 in FIG. 51. In this embodiment with two springs, a firstspring exerts a proximal force on the needles 546 while a second springexerts a distal force on the actuating rod 50 inside the handle. Inanother configuration (not shown), instead of a second set of springs ora trigger, the physician manually retracts the needles 546 proximallyback into the needle housing 516. In another configuration, a handle(not shown) attached to the proximal end of the device 520 is similar tothe handle as shown in FIG. 40.

[0253] Embodiments of FIGS. 52A-59

[0254]FIG. 52A is a perspective view of the suture introducer head 522and the hollow elongated body 514 of FIG. 41 with another embodiment ofthe suture clasp arms 630, 630′. In this embodiment, the ends of thesuture are provided with special loops 41 that are configured to engagewith the needles (as described below). FIG. 52B is a cross-sectionalview of the device of FIG. 52A. FIGS. 53A-53B are perspective views ofone configuration of the suture clasp arms 630, 630′ shown in FIG. 52A.FIG. 54 is a perspective view of the device of FIG. 52A with the sutureclasp arms 630, 630′ partially deployed. FIGS. 55-56 are perspectiveviews of the device of FIG. 52A with the suture clasp arms 630, 630′fully deployed. FIG. 56 further shows two flexible needles 650 engagingthe suture clasp arms 630, 630′.

[0255] As shown in FIG. 52A, a first suture clasp arm 630 comprises ahinge portion 636 at a distal side with an aperture 642 for a pivot pin502 (FIG. 43C). The first suture clasp arm 630 further comprises acurved portion 638 for the distal end of an actuating rod 50 (as in FIG.43B) and the hinge portion 636 at a distal side of the second sutureclasp arm 630′ (FIG. 53B). The first suture clasp arm 630 furthercomprises an annular recess 632 for holding a suture looped end 41 andfor receiving the distal portion of a needle. The arm 630 furthercomprises a slit 640 for the length of the suture 40, and a sloped end634. The distal side of the arms 630, 630′ are connected to theactuating rod 50 via a pivot pin 502 (FIG. 43C) such that the proximalsides of the arms 630, 630′ may move away from the suture introducerhead 522, as shown in FIG. 54, to a position where the proximal sidesare fully extended outwardly away from the distal sides of the arms 630,630′ shown in FIGS. 52A-52B. The extended proximal sides may also beretracted towards and into the suture introducer head 522 to a retreatedposition (similar to the position shown in FIG. 41).

[0256]FIG. 53B illustrates the second suture clasp arm 630′, which isthe other half of a two-arm suture clasp member. The second suture clasparm 630′ is similar to first suture clasp arm 630 except the secondsuture clasp arm 630′ does not have a curved portion 638 for the distalend of an actuating rod 50 (as in FIG. 43B).

[0257] In one embodiment, the length of the first suture clasp arm 630is about 0.174 inches. In one embodiment, the length of both of thesuture clasp arms 630, 630′ together in their fully extended position(deployed with both arms parallel to each other) is preferably about0.288 inches. In other configurations of the suture clasp arms 630,630′, the dimensions may vary.

[0258] As shown in FIGS. 55-56, each of the flexible needles 650comprises an elongated shaft, a pointed, generally conical penetratingdistal tip 654, and a groove or shoulder 652 at the base of the distaltip 654 near the distal end. The circumference of the looped end 41 isslightly smaller than that of the base of the conical tip 654, so thatthe needle groove 652 acts as a detent mechanism or suture catch. In apreferred configuration, the grooves 652 extend around the completecircumference of the needles 650. In other configurations, the grooves652 are partially circumferential along the radial edge of the needles650. The loops 41 correspond generally in circumference to grooves 652of the needles 650, and are sufficiently resilient to expand incircumference in response to the downward force of the needles 650, soas to slide over the conical tip 654.

[0259] In one embodiment, the looped end 41 comprises an eyelet that isformed as a unitary, integral part of the suture 40. The suture eyeletcomprises a flat, thin portion of suture material having a centralopening that is slightly smaller than the base of the tip 654. Theperiphery of the disc is contoured to match that of the recess 632 ofthe clasp arms. The disc is sized to fit within the recess and to beretained therein by interference fit. The looped end 41 of the suture 40may be formed by heating one end of a length of suture such as by astream of hot gas until the end becomes a ball-shape and pliable. Theball-shaped end is then deformed by compressing it into a disc shapewhile the suture material is still pliable. A sharpened hypotube is thenused to punch out the hole near the center of the disc-shaped end suchthat the disc-shaped end forms the eyelet. If desired, the disk may bebent relative to the strand while the material is pliable to put apermanent set in the bent suture. In one configuration, the suturecomprises a monofilament or plastic suture material, such as prolene ordeclene. In one method of forming the looped end, instead of heating theend of a suture length, the suture end is simply compressed and a holeis formed thereafter. The end may be further cut or stamped into acircle shape.

[0260] In another configuration, instead of pre-forming the hole in thesuture end, the actuation of the needles 650, as described below withreference to FIG. 56, is used to form the hole and fasten the ends ofthe suture to the needles 650.

[0261] In another configuration, a separately-formed loop isinsert-molded, glued, crimped or otherwise attached to the end of alength of suture. The loop may be in the shape of a circle, oval,triangle, rectangle, hexagon, octagon, etc.

[0262] The general use and operation of the suture clasp arms 630, 630′in FIGS. 52A-56 is substantially similar to the use and operation of thesuture clasp arms 524 described above with reference to FIGS. 41-48.Specifically, the looped ends 41 of the suture 40 are placed within theannular recess 632 of the suture clasp arms 630, 630′ (FIGS. 52A and54). The suture introducer head 522 is inserted into biological tissue(similar to FIG. 47), and the suture clasp arms 630, 630′ are deployedradially outward (FIG. 55). The penetrating flexible needles 650 passthrough the biological tissue to be sutured (similar to FIG. 47) andengage the suture clasp arms 630, 630′ (FIG. 56).

[0263] When the needle points 654 pass through the looped ends 41 of thesuture 40, the looped ends 41 elastically stretch slightly, so as tocircumferentially flex momentarily. As the needles 650 continue toadvance distally, the looped ends 41 relax, fall into the grooves 652,and fasten around the needle grooves 652, such that pulling the needles650 proximally causes the suture ends 41 to follow the proximal movementof the needles 650. Thus, the grooves 652 provide the same generalfunction as the suture catches 38 (FIG. 41) described above withreference to FIGS. 41-42 and 47. In an alternative embodiment, theneedles are formed without a groove or shoulder, and the shaft of theneedle is sized relative to the opening in the eyelet to provide aninterference fit therebetween.

[0264] FIGS. 58-59 are perspective views of a suturing device 660 with afour-arm suture clasp member used with the device of FIGS. 1C-1D. Thesuturing device 660 shown in FIGS. 58-59 comprises four needle apertures670 and four suture clasp arms 662-668. Each of the four suture clasparms 662-668 comprises an annular recess and a slit for the length ofthe suture. In one embodiment, two sutures are used with the deviceshown in FIGS. 58-69, each of which is held by a pair of suture clasparms. Each suture has a loop at either end which is placed within one ofannular recesses of a suture clasp arm. The arms 662-668 mayalternatively be provided with one of the other types of suture claspstructures disclosed herein.

[0265]FIG. 60 is a perspective, exploded view of another handleconfiguration 700 attached to the proximal end of the device of FIG. 41,the device of FIG. 48 or the device of FIG. 52A. FIG. 61 is aperspective view of the handle of FIG. 60. In FIG. 60, the handle 700comprises a thumb ring 702, a plunger 704, a plunger distal end 706, amain housing 710, a proximal aperture 708, a finger ring 712, a slopedfloater peg slot 714, a floater clamp slot 715, a distal end aperture716, a floater 720, a peg 718, a floater clamp lock 722, a floater clamp724, a drive wire (actuating rod 50) clamp 726, a needle holder backer728, a needle holder 730, a floater clamp peg 732, a floater clampaperture 734, a spring 736, at least one plunger peg 738, L-shaped lockrecess 740 and an extrusion (hollow elongated body 514) clamp 742.

[0266] The spring 736, the floater 720, the floater clamp lock 722, thefloater clamp 724, the drive wire clamp 726, the needle holder backer728, the needle holder 730 and the extrusion clamp 732 are operativelyreceived within the main housing 710. The shaft of the plunger 704 isslidably received through the floater 720, the floater clamp lock 722and the floater clamp 724.

[0267] The square- or rectangular-shaped shaft of the plunger 704 fitswithin the square- or rectangular-shaped axial recess of the floater720, such that rotating the plunger 704 clockwise causes the floater 720to rotate clockwise as well. The plunger distal end 706 is adapted tosnap into or otherwise attach itself into the needle holder backer 728.The plunger pegs 738 are slidably received along the L-shaped lockrecess 740 formed on the interior of the main housing 710.

[0268] In a preferred configuration, the L-shaped recess lock 740, thefloater peg slot 714 and the floater clamp slot 715 are all molded,carved or otherwise formed on the interior of the main housing 710. Thespring 736 provides a proximal biasing force on the plunger pegs 738 andthe plunger 704. The spring 736 also provides a distal biasing force onthe floater 720.

[0269] The floater peg 718 is slidably received along the slopingfloater peg slot 714. The distal end of the floater 720 snaps and locksinto the proximal portion of the floater clamp lock 722. The floaterclamp lock 722 is preferably glued, bonded or otherwise attached to thefloater clamp 724. The drive wire clamp 726 fits within the aperture 734of the floater clamp 724. The drive wire clamp 726 is glued, bonded orotherwise attached to a proximal portion of a drive wire or theactuating rod 50 of FIG. 52B.

[0270] The extrusion (hollow elongated body 514) clamp 742 is glued,bonded or otherwise attached to a proximal portion of the hollowelongated body 514 of FIG. 52A. The needle holder 730 is preferablyglued, bonded or otherwise attached to the needle holder backer 728. Theproximal portion of the needles 546 of FIG. 47 or the needles 650 ofFIG. 55 are preferably glued, bonded, molded into or otherwise attachedto the needle holder 730.

[0271] The use and operation of the handle 700 will now be describedwith reference to FIG. 60. While the handle 700 is in its initial stateand shipped to end-users, the plunger pegs 738 within the L-shaped lockrecess 740 prevent the plunger 704 from moving distally relative to themain housing 710. When a physician rotates the plunger 704 clockwise bytwisting the thumb ring 702, the plunger pegs 738 move circumferentiallyalong the L-shaped lock recess until the plunger pegs 738 are positionedto slide distally down the longitudinal part of the L-shaped lock recess740.

[0272] As the physician rotates the plunger 704, the floater 720 alsorotates clockwise. The peg 718 moving within the sloped floater peg slot714 causes the floater 720 to move proximally. Because the drive wireclamp 726 is attached to the drive wire or actuating rod 50 (FIG. 52A),the proximal movement of the floater 720 causes the floater clamp lock722, the floater clamp 724, the drive wire clamp 726, and the actuatingrod 50 to move proximally, such that the suture clasp arms 630, 630′deploy radially outward (FIGS. 52A-52B).

[0273] Once the plunger 704 is fully rotated and the plunger pegs 738are positioned to slide distally down the longitudinal part of theL-shaped lock recess 740, the physician may advance the plunger 704distally. The distal movement of the plunger 704 causes the needles 546(FIG. 47) or the needles 650 (FIG. 55) to advance distally, penetratethe biological tissue, and engage the suture clasp arms 524, 630, 630′(FIG. 47 and FIG. 55).

[0274] One of the advantages of the handle 700 is that the L-shaped lockrecess 740 prevents the plunger 704 and the needles 546 (FIG. 47) or theneedles 650 (FIG. 55) from advancing prematurely. This preventsunintentional deployment of the needles 546, 650 which may cause damageto the patient's tissues 14, 22 (FIG. 1D).

[0275] Six-Arm and Eight-Arm Embodiments

[0276] FIGS. 62-65 illustrate another suture device configuration 750.FIG. 62 is a perspective view of the suture device 750 with six sutureclasp arms 756-766 (only three of which are visible in FIG. 62). FIG. 63is a perspective view of the device 750 of FIG. 62 with the suture clasparms 756-766 fully deployed. FIG. 64 is a perspective view from thedistal end of the device 750 of the six suture clasp arms 756-766 ofFIG. 62. FIG. 65 is a perspective view of the device of FIG. 62 with thesuture clasp arms fully deployed and a set of needles engaging thesuture clasp arms.

[0277] In FIG. 62, the structure of the suture introducer head 752 issubstantially similar to the suture introducer head 522 of FIG. 52A,except the suture introducer head 752 in FIG. 62 comprises six suturearm apertures 508 and six needle apertures 510. Similarly, the structureof the hollow elongated body 754 in FIG. 62 is substantially similar tothe structure of the hollow elongated body 514 in FIG. 52A, except thehollow elongated body 754 in FIG. 62 comprises six needle lumens (notshown) to house the needles 650. Alternatively, the hollow elongatedbody 754 and the suture introducer head 752 may be one integrated piece,similar to the device 515 in FIG. 48.

[0278] In another embodiment, the suture device may have eight sutureclasp arms, eight suture clasp arm apertures, eight needles, eightneedle apertures, eight needle lumens and four sutures.

[0279] In a preferred embodiment, there is a handle (not shown) at theproximal end of the suture device 750 which allows a physician tooperate the suture device 750. The handle may be similar to any one ofthe handle embodiments described above and below, except that the handlefor suture device 750 is adapted to operate six suture clasp arms andsix needles.

[0280] The structure of the suture clasp arms 756-766 of FIG. 62 issubstantially similar to the structure of the suture clasp arm 630′ inFIG. 53B. Alternatively, the structure of the suture clasp arms 756-766is substantially similar to the suture clasp arm 630 (with a curvedportion 638) in FIG. 53A. As shown in FIG. 63, each suture clasp arm756-766 comprises an annular recess 632 for holding a looped end 41 of asuture 40. As shown in FIG. 64, each suture clasp arm 756-766 comprisesa hinge portion 636, which is similar to the hinge portion 636 shown inFIG. 53B.

[0281] In FIG. 64, the suture introducer head 752 comprises a centerring 770 with six spokes 772. Each hinge portion 636 is operativelyattached to a spoke 772 by a pivot pin (not shown), which issubstantially similar in structure and function to the pivot pin 502 inFIG. 52B. The center ring 770 is attached to an actuating rod (notshown), which is substantially similar in structure and function to theactuating rod 50 in FIG. 52B.

[0282] In addition, the structure of the suture 40 and the needles 650in FIG. 62 is substantially similar to the structure of the suture 40and the needles 650 in FIG. 52A. In FIG. 62, there are six needles 650and three sutures 40. Each suture 40 has a loop 41 at each end of thesuture 40.

[0283] The general use and operation of the suture device 750 in FIGS.62-65 is substantially similar to the use and operation of the suturedevices described above with reference to FIGS. 41-48 and FIGS. 52A-56.Specifically, in FIG. 63, a first looped end 41 of a first suture 40 isplaced within the annular recess 632 of a first suture clasp arm 756,and the second looped end 41 of the same suture 40 is placed within theannular recess 632 of a second suture clasp arm 762. The second sutureclasp arm 762 is on the opposite side (180 degrees) of the sutureintroducer head 752 in relation to the first suture clasp arm 756.Similarly, a first looped end 41 of a second suture 40 is placed withinthe annular recess 632 of a third suture clasp arm 766, and the otherlooped end 41 of the second suture 40 is placed within the annularrecess 632 of a fourth suture clasp arm 760. The third suture clasp arm766 is on the opposite side (180 degrees) of the suture introducer head752 in relation to the fourth suture clasp arm 760. Lastly, a firstlooped end 41 of a third suture 40 is placed within the annular recess632 of a fifth suture clasp arm 758, and the other looped end 41 of thethird suture 40 is placed within the annular recess 632 of a sixthsuture clasp arm 764 (FIG. 64).

[0284] To assist a user in placing the six suture loops 41 properly, thesuture clasp arms 756-766 may be colored to distinguish each sutureclasp arm pair. For example, suture clasp arms 756 and 762 may becolored red, suture clasp arms 760, 764 may be colored white, and sutureclasp arms 758 and 766 may be colored blue. Alternatively, instead ofcolors, the suture clasp arm pairs may have another type of indication,such as a marking. Alternatively, the suture introducer head 752 or theelongated body 754 may include an indication, such as coloring ormarkings to indicate the suture clasp arm pairs.

[0285] In operation, the suture introducer head 752 of FIG. 62 isinserted into biological tissue 22 (similar to FIG. 47). The physicianpreferably uses a handle to deploy the six suture clasp arms 756-766radially outward (FIG. 63). The physician uses the handle to advance thesix penetrating flexible needles 650 through the biological tissue 22 tobe sutured (similar to FIG. 47) and to engage the suture clasp arms756-766 (FIG. 56) simultaneously. Alternatively, in another method, thethree pairs of needles 650 advance distally through the tissue 22 andengage the suture clasp arms 756-766 at different times.

[0286] When the needles 650 engage the suture clasp arms 756-766, theneedles 650 capture the ends 41 of the sutures 40. The needles 650 arethen withdraw proximally with the ends 41 of the sutures 40 attached.Once the needles 650 are drawn into the needle apertures 510, thecombination -of the circular detents or grooves of the needles 650 andthe inside surface of the suture introducer head 752 securely holds thesutures 40 or creates a lock on the sutures 40 such that withdrawing thesuture device 750 will not cause the suture ends 41 to slip out of theapertures 510.

[0287] After the needles 650 pull the ends 41 of the three sutures 40proximally out of the tissue 22, the physician removes the suture device750 from the patient's tissues 22, 14 (FIG. 1B). The physician thenreleases the suture ends 41 from the needles 650 and ties three knots tosecure the three sutures 40 at the suture site 26 (FIG. 1B).

[0288] Compact, Four-Arm Embodiment

[0289] FIGS. 66-69 illustrate another suture device configuration 800 ofthe present invention. FIG. 66 is a perspective view from the distal endof the suture device 800 with four suture clasp arms 804-810. FIG. 67 isa perspective view of the suture device 800 of FIG. 66 with the sutureclasp arms 804-810 fully retracted. FIG. 68 is a perspective view of thesuture device 800 of FIG. 66 with the suture clasp arms 804-810partially deployed. FIG. 69 is a perspective view of the suture device800 of FIG. 66 with the suture clasp arms 804-810 fully deployed and aset of needles 650.

[0290] In FIG. 66, the structure of the suture introducer head 801 issubstantially similar to the suture introducer head 522 of FIG. 52A,except the suture introducer head 801 of FIG. 66 has four suture clasparm apertures 508, four needle apertures and four needle guides 802.Similarly, the structure of the hollow elongated body 870 attached toproximal end of the suture introducer head 801′ of FIG. 66 issubstantially similar to the elongated body 514 of FIG. 52A, except theelongated body 870 attached to the suture introducer head 801 has fourneedle lumens (not shown). Alternatively, the hollow elongated body 870and the suture introducer head 801 may be one integrated piece, similarto the device 515 in FIG. 48.

[0291] In a preferred embodiment, there is a handle (not shown) at theproximal end of the suture device 800 which allows a physician tooperate the suture device 800. The handle may be similar to any one ofthe handle embodiments described above and below, except that the handlefor suture device 800 is adapted to operate four suture clasp arms andfour needles.

[0292] Like the suture clasp arm 630 in FIG. 52A, the suture clasp arms804-810 of FIGS. 66-69 comprise hinge portions 820-826, apertures forpivot pins (e.g., an aperture 846 and a pivot pin 842 are shown in FIG.69), annular recesses for holding looped ends of a suture 40 (e.g., an,annular recess 844 is shown in FIG. 68), sloped ends 848-854 forfacilitating deployment of the suture clasp arms 804-810, and slits856-862 for the lengths of sutures 40.

[0293] The suture clasp arms 804-810 further comprise sloped sidesurfaces 812-818 and curved recesses 828-834. The sloped side surfaces812-818 facilitate deployment and/or retraction of the suture clasp arms804-810 when the sloped side surfaces 812-818 come in contact with theedges of the suture clasp arm apertures 508. The curved recesses 828-834are configured to accommodate the hinge portions 820-826 of the sutureclasp arms 804-810. For example, the curved recess 828 accommodates thehinge portion 826 and provides sufficient space for both suture clasparms 804, 810 to deploy and retract without hindering each other.

[0294] In FIG. 66, the suture device 800 comprises a central hingemember 836 which is attached to an actuating rod (not shown, but similarto the actuating rod 50 in FIG. 52B) via an actuating rod aperture 838.The center hinge member 836 comprises four pivot pins, such as the pin848 shown in FIG. 69. The hinge portions 820-826 of the suture clasparms 804-810 rotate or pivot about the pivot pins. From a perspectiveview, such as FIG. 66, the suture clasp arms 804-810 and the centralhinge member 836 resemble a pin-wheel.

[0295] The suture device 800 further comprises a spreader 840 (FIGS.67-69). The structure of the spreader 840 is slightly different than thespreader 523 in FIGS. 43D and 52A, but the function is the same. Likethe spreader 523 described above with reference to FIGS. 43D and 52A,the distal end of the spreader 840 in FIG. 67 is configured to spreadthe four suture clasp arms 804-810 into their deployed position when thecentral hinge member 836 is moved proximally.

[0296] The general use of the suture device 800 in FIGS. 66-69 issubstantially similar to the use and operation of the suture devicesdescribed above with reference to FIGS. 41-48, 52A-56 and 62-65.Specifically, a first looped end 41 of a first suture 40 is placedwithin the annular recess of a first suture clasp arm 804, and thesecond looped end 41 of the same suture 40 is placed within the annularrecess of a second suture clasp arm 808. The second suture clasp arm 808is on the opposite side (180 degrees) of the suture introducer head 801in relation to the first suture clasp arm 804. Similarly, a first loopedend 41 of a second suture 40 is placed within the annular recess of athird suture clasp arm 806, and the other looped end 41 of the secondsuture 40 is placed within the annular recess of a fourth suture clasparm 810. The third suture clasp arm 806 is on the opposite side (180degrees) of the suture introducer head 801 in relation to the fourthsuture clasp arm 810.

[0297] As shown in FIG. 66, the suture clasp arms 804-810 do not deployand retract in the same manner as the four suture clasp arms 660-668 ofthe suturing device 660 shown in FIG. 59 (and other suturing devicesdisclosed herein, such as the suturing device 520 shown in FIG. 41 andthe suturing device shown in FIG. 52A). In FIG. 59, each suture clasparm 660-668 (and a needle associated with each suture clasp arm 660-668)deploys and retracts within a two-dimensional plane, and the centrallongitudinal axis of the suturing device 660 lies within each plane.

[0298] By comparison, in FIG. 66, the suture clasp arms 804-810 deployand retract off-center in relation to the central longitudinal axis ofthe suture device 800. In other words, each suture clasp arm 804-810(and a needle 650 (FIG. 69) associated with each suture clasp arm804-810) deploys and retracts within a two-dimensional plane, and thecentral longitudinal axis of the suturing device 800 is offset ordisplaced from each plane. The plane associated with a first sutureclasp arm 804 is preferably parallel to the plane associated with asecond suture clasp arm 808. Likewise, the plane associated with a thirdsuture clasp arm 806 is preferably parallel to the plane associated witha fourth suture clasp arm 810. All of these planes are preferablyparallel to the longitudinal axis.

[0299] This pin-wheel configuration of the suture clasp arms 804-810shown in FIG. 66 allows the suture device 800 to be built compactly witha relatively small diameter. In one embodiment, the suture device 800 issized to fit an 8 french catheter or tube. Alternatively, in otherembodiments, the suture device 800 may be sized to fit a catheter ortube that is smaller than or larger than 8 french.

[0300] In another embodiment of the suturing device 800, the centrallongitudinal axis is angularly offset from at least one of the fourplanes such that the central longitudinal axis intersects at least oneof the four planes.

[0301] In another embodiment, the plane associated with a first sutureclasp arm 804 intersects the plane associated with a second suture clasparm 808. In addition, the plane associated with a third suture clasp arm806 may intersect the plane associated with a fourth suture clasp arm810.

[0302] The needle guides 802 shown in FIG. 69 preferably direct the tipsof the needles 650 such that they deploy distally and retract proximallyalong a path that is curved in three dimensional space and which isoffset from the central longitudinal axis of the suture device 800. Ineffect, the needletips move both sideways and outwardly relative to thecentral axis. Stated another way, if the needle tips in their retreatedposition lie in respective planes in which the central longitudinal axisalso lies, then the path of these needle tips will diverge from theplanes as the tips move from their retracted position to their extendedposition.

[0303] Alternatively, in another embodiment, each suture clasp arm804-810 (FIG. 66) deploys and retracts within a two-dimensional planewhich is offset from the central longitudinal axis of the suture device800, but each needle 850 deploys distally and retracts proximally in atwo dimensional plane.

[0304] Alternatively, in another embodiment, each needle 850 (FIG. 69)deploys distally and retracts proximally within a two-dimensional planewhich is offset from the central longitudinal axis of the suture device800, but each suture clasp arm 804-810 deploys distally and retractsproximally in an arc or curve.

[0305] Alternatively, in other embodiments, this pin-wheel configuration(where the central longitudinal axis of the suturing device 800 isoffset from each plane associated with a suture clasp arm 804-810) andthe related variations described above are embodied in suturing deviceswith less than or greater than four suture clasp arms, such as two, sixor eight suture clasp arms.

[0306] In operation, the suture introducer head 802 of FIG. 66 isinserted into biological tissue with the suture arms 804-810 withdrawn,as shown in FIG. 67 (similar to FIG. 47). The physician preferably usesa handle to deploy the four suture clasp arms 804-810 radially outward,as shown in FIGS. 68 and 69. The physician uses the handle to advancethe four penetrating flexible needles 650 through the biological tissueto be sutured (similar to FIG. 47) and to engage the suture clasp arms804-810 (FIG. 69) simultaneously. Alternatively, in another method, thetwo pairs of needles 650 advance distally through the tissue and engagethe suture clasp arms 804-810 at different times.

[0307] Once the needles 650 pull the ends 41 of the two sutures 40proximally out of the tissue 22, the physician ties two knots to securethe two sutures 40.

[0308] Movable Sheath

[0309] FIGS. 70-71 illustrate a movable sheath 872 that may be used withthe suture devices described above. For purposes of illustration, thesheath 872 is shown in FIGS. 70-71 in use with the suture device 800 ofFIG. 67. Alternatively, the sheath 872 may be adapted for use with anyof the suture devices described above with reference to FIGS. 1A-69.

[0310] In FIG. 70, the sheath 872 comprises a thin-wail catheter whichcovers the entire suture device 800 or at least a distal portion of thesuture device 800. In one configuration, the sheath 872 includes anopening at its distal end. In another configuration, the sheath 872 doesnot include an opening at its distal end, but may have a perforationwhich can be torn by downward pressure of the suture device 800 tocreate an opening. The sheath 872 is preferably formed or placed on thesuture device 800 during manufacturing. In one configuration, the sheath872 comprises polyimide. Alternatively, other materials may be usedinstead of or in addition to polyimide.

[0311] One of the advantages to the sheath 872 is that it protects theexposed portions of the sutures 40 from premature displacement as thesuture device 800 is inserted distally through the CSI 6, the patient'stissue 14 and the vessel 22. The sheath 872 may also protect otherexterior parts of the suturing device 800 and/or the tissue 14 andincision 26 (FIG. 70). In one embodiment, the sheath 872 also protectsthe exposed portions of the sutures 40 as the suture device 800 iswithdrawn proximally through the CSI 6, the patient's tissue 14 and thevessel 22.

[0312] In operation, after the suture device 800 is inserted through theCSI 6, the patient's tissue 14 and the vessel 22, the user removes thesheath 872 at least partially from the suture introducer head 801. Thisis shown in FIGS. 70-71. There may be a number of ways to remove thesheath 872. In one embodiment, the user manually removes the sheath 872by sliding it proximally along the suture device 800. In anotherembodiment, the plunger 704 of the handle 700 in FIG. 60 is attached tothe sheath 872, such that rotating the plunger 704 causes the sheath 872to slide proximally.

[0313] In addition, in one embodiment, the sheath 872 may be advanceddistally over the suture introducer head 801 after the needles 650 havecaptured the ends 41 of the sutures 40 and retracted into the needlelumens. In this manner, the sheath 872 protects the exposed portions ofthe sutures 40 as the suture device 800 is withdrawn proximally throughthe CSI 6, the patient's tissue 14 and the vessel 22.

[0314] Occlusion Devices

[0315] FIGS. 72-73 illustrate occlusion devices 880, 890 that may beused with the suture devices described above to temporarily occlude theincision 26 and minimize the amount of blood escaping from the bloodvessel 16 through the incision 26. The occlusion devices 880, 890 arepreferably adapted to allow blood to flow through the blood vessel 16itself uninterrupted. Alternatively, in another embodiment, theocclusion devices 880, 890 are adapted to occlude the entire bloodvessel 16, including the incision 26.

[0316] For purposes of illustration, the occlusion devices 880, 890 areshown in FIGS. 72-73 in use with the suture device of FIG. 52A.Alternatively, the occlusion devices 880, 890 may be adapted for usewith any of the suture devices described above with reference to FIGS.1A-69.

[0317] In FIG. 72, the occlusion device comprises a balloon 880 which isadapted to temporarily occlude the incision 26 to be sutured. Theballoon 880 may comprise polyethylene, polyurethane, other polymers orany other material with similar properties. The balloon 880 is attachedto a hollow tube 882 which is attached to a lumen (not shown) within thesuture introducer head 522 and the hollow elongated body 514.Alternatively, the hollow tube 882 may extend through the lumen withinthe suture introducer head 522 and the hollow elongated body 514, andmay slide within such lumen. The hollow tube 882 may be flexible orsubstantially rigid. The hollow tube 882 is used to inflate the balloon880. The balloon 882 may be inflated with saline solution or any fluidthat is safe for internal occlusion devices.

[0318] In operation, inflation of the balloon 880 is initiated after (1)the needles capture the ends of the suture 40 from the suture clasp arms630, 630′ and (2) the suture clasp arms 630, 630′ are retracted into thesuture introducer head 522. This is shown in FIG. 72. The balloon 880temporarily occludes the incision 26 while the suture introducer head522 is being withdrawn proximally from the tissue 14 and the physicianis tying a knot with the suture ends. The physician slides the knotdistally toward the incision 26. Before the physician tightens the knot,the physician deflates the balloon 880 and withdraws the balloon 880from the vessel 16 and the tissue 14. Finally, the physician thentightens the knot to close the incision 26.

[0319] In FIG. 73, the occlusion device comprises an inverting member890, such as the inverting members shown and described in U.S. Pat. No.5,944,730 entitled “DEVICE AND METHOD FOR ASSISTING END-TO-SIDEANASTOMOSIS” filed on Mar. 6, 1997, the entirety of which isincorporated by reference herein. The inverting member 890 is attachedto an actuator 892 which extends through a lumen (not shown) within thesuture introducer head 522 and the hollow elongated body 514. Asdescribed in the above-referenced patent, the inverting member 890comprises: an elongated shaft or tube and an expandable inverting memberwhich forms a cup or umbrella-like structure that can be used to form asealed pocket against the inner wall 22 of the vessel 16.

[0320] Like the occlusion balloon 880 described above with reference toFIG. 72, the inverting member 890 is adapted to temporarily occlude theincision 26 to be sutured. In operation, the inverting member 890protrudes from the distal tip of the suture introducer head 522. Theinverting member 890 is expanded from a collapsed configuration to anexpanded configuration after (1) the needles capture the ends of thesuture 40 from the suture clasp arms 630, 630′ and (2) the suture clasparms 630, 630′ are retracted into the suture introducer head 522. Thisis shown in FIG. 73. The inverting member 890 temporarily occludes theincision 26 while the suture introducer head 522 is being withdrawnproximally from the tissue 14 and the physician is tying a knot with thesuture ends. The physician slides the knot distally toward the incision26. Before the physician tightens the knot, the physician collapses theinverting member 890 so that the expanded cup is contracted against theshaft, and withdraws the inverting member 890 from the vessel 16 and thetissue 14. Finally, the physician then tightens the knot to close theincision 26.

[0321] Alternate Handle Embodiment

[0322]FIG. 74A is a perspective view of another embodiment of a handle900 capable of being attached to the proximal end of the device of FIG.41, the device of FIG. 48 or the device of FIG. 52A. Similarly, FIG. 74Bis a perspective view of another embodiment of a handle 900 adapted toseparately actuate the first and second needles. A portion of the mainhousing 910 has been removed in FIGS. 74A and 74B to expose theinterior. FIGS. 75A and 75B are exploded, perspective views of theembodiment shown in FIG. 74A. FIG. 76A is an exploded, perspective viewof the embodiment shown in FIG. 74B, and FIGS. 76B-D schematicallyillustrate various embodiments of the needle drivers adapted toseparately actuate the first and second needles. FIGS. 74B and 76A-Dwill be described more fully below in connection with thenon-simultaneous actuation of the first and second needles.

[0323] In FIGS. 74A, 75A, and 75B, the handle 900 comprises a thumb ring902, a plunger 904, a plunger distal end 906, a main housing 910, aproximal aperture 908, a finger ring 912, a sloped floater peg slot 914,a floater clamp slot 915, a distal end aperture 916, a floater 920, apeg 918, a floater clamp lock 922, a pair of finger grips 924, a pair ofneedle holding apertures 926, a rotator 930, a 928 rotator grip, adistal portion 932 of the rotator 930, a central lumen 934 in therotator 930, a spring 936, at least one plunger peg 938, and an L-shapedlock recess 940.

[0324] In a preferred embodiment, the handle 900 further comprises othermembers which are substantially similar to the members of the handle 700described above with reference to FIGS. 60 and 61. These members includea floater clamp (not shown), a drive wire clamp for an actuating rod 50(e.g., FIG. 52B), a floater clamp peg, a floater clamp aperture, and anextrusion clamp for a hollow elongated body 514 (e.g., FIG. 52B).

[0325] As shown in FIG. 74A, at least a portion of the spring 936, theplunger 904, the rotator 930, the floater 920, the floater clamp lock922, the floater clamp (not shown), the drive wire clamp (not shown),and the extrusion clamp (not shown) are operatively received within themain housing 910, similar to FIG. 60. The distal portion 906 of theplunger 904 is slidably received through the rotator 930, the floater920, the floater clamp lock 922 and the floater clamp (not shown),similar to FIG. 60.

[0326] The square- or rectangular-shaped distal portion 932 of therotator 930 fits within the square- or rectangular-shaped axial recessof the floater 920, such that rotating the rotator 930 clockwise causesthe floater 920 to rotate clockwise as well. The plunger pegs 938 areslidably received along the L-shaped lock recess 940 formed on theinterior of the main housing 910.

[0327] In a preferred configuration, the L-shaped recess lock 940, thefloater peg slot 914 and the floater clamp slot 915 are all molded,carved or otherwise formed on the interior of the main housing 910. Thespring 936 provides a proximal biasing force on the plunger peg 938 andthe plunger 904. The spring 936 also provides a distal biasing force onthe floater 920.

[0328] The floater peg 918 is slidably received along the slopingfloater peg slot 914. The distal end of the floater 920 snaps and locksinto the proximal portion of the floater clamp lock 922. The floaterclamp lock 922 is preferably glued, bonded or otherwise attached to thefloater clamp, similar the one shown in FIG. 60. Similar to the handle700 of FIG. 60, the drive wire clamp fits within the aperture of thefloater clamp. The drive wire clamp (not shown) is glued, bonded orotherwise attached to a proximal portion of a drive wire or an actuatingrod 50 (e.g., FIG. 52B).

[0329] The extrusion clamp (not shown) is glued, bonded or otherwiseattached to a proximal portion of a hollow elongated body 514 (e.g.,FIG. 52A). The proximal portion of the needles 546 of FIG. 47 or theneedles 650 of FIG. 55 are preferably glued, bonded, molded into orotherwise attached to the needle holding apertures 926 of the plunger904.

[0330] The use and operation of the handle 900 will now be describedwith reference to FIGS. 74A, 75A, and 75B. While the handle 900 is inits initial state and shipped to end-users, the plunger pegs 938 withinthe L-shaped lock recess 940 prevent the plunger 904 from movingdistally relative to the main housing 910. When a physician rotates therotator 930 clockwise by twisting the rotator grip 928, the plunger pegs938 move circumferentially along the L-shaped lock recess 940 until theplunger pegs 938 are positioned to slide distally down the longitudinalpart of the L-shaped lock recess 940.

[0331] As the physician rotates the rotator 930, the floater 920 alsorotates clockwise. The peg 918 moving within the sloped floater peg slot914 causes the floater 920 to move proximally. Because the drive wireclamp is attached to the drive wire or actuating rod 50 (e.g., FIG.52A), the proximal movement of the floater 920 causes the floater clamplock 922, the floater clamp, the drive wire clamp, and the actuating rod50 to move proximally, such that the suture clasp arms 630, 630′ deployradially outward (FIGS. 52A-52B). As shown in FIG. 75B, the proximalside of the rotator grip 928 preferably has a marking 842 whichindicates the direction of rotation (e.g., clockwise) required to deploythe suture clasp arms 630, 630′.

[0332] Full rotation of the rotator 930 disables the lock so as to allowthe plunger 902 to move longitudinally relative to the main housing 910.When the rotator 930 is fully rotated, the plunger pegs, 938 arepositioned to slide distally down the longitudinal part of the L-shapedlock recess 940, and the physician may advance the plunger 904 distally.The distal movement of the plunger 904 causes the needles 546 (FIG. 47)or the needles 650 (FIG. 55) to advance distally, penetrate thebiological tissue, and engage the suture clasp arms 524, 630, 630′ (FIG.47 and FIG. 55).

[0333] One of the advantages of the handle 900 is that the L-shaped lockrecess 940 prevents the plunger 904 and the needles 546 (FIG. 47) or theneedles 650 (FIG. 55) from advancing prematurely. This preventsunintentional deployment of the needles 546, 650 which may cause damageto the patient's tissues 14, 22 (FIG. 1D).

[0334] Moving Arms and/or Needles at Different Times

[0335] In the embodiments described herein, the suturing device may beconfigured to deploy the arms at different times, to deploy the needlesto engage the suture at different times or to deploy one arm and itsassociated or corresponding needle and then deploy another arm and itsassociated or corresponding needle. For example, FIG. 77 illustrates thesuture device of FIG. 56 adapted to move a first needle 650 distally toengage a first suture clasp arm 630 before moving a second needle 650′(FIG. 78) distally to engage a second clasp arm 630′. FIG. 78illustrates the suture device of FIG. 77 with the second needle 650′moving distally to engage the second suture clasp arm 630′. In certainembodiments, the first needle 650 engages the first suture clasp arm 630before the second needle 650′ engages the second suture clasp arm 630′.In other embodiments, the first needle 650 engages the first sutureclasp arm 630 before the second needle 650′ moves distally. In stillother embodiments, the first and second suture clasp arms 630, 630′ aredeployed non-simultaneously. For example, the second suture clasp arm630′ is deployed after the first suture clasp arm 630 is deployed andafter the first needle 650 engages the first suture clasp arm 630.

[0336] Likewise, the first and second needles 650, 650′ may be movedproximally at different times. For example, the first needle 650 may bewithdrawn proximally after it captures one end of the suture 40 beforethe second needle 650′ is withdrawn proximally after the second needle650′ captures the other end of the suture 40. In one embodiment, thefirst and second needles 650 and 650′ are separably actuatable such thateach needle is deployed independently of the other needle at differenttimes. Alternatively, in other embodiments, the first and second needles650 and 650′ are deployed by a common actuator adapted to first deployone needle, and then to deploy the other needle.

[0337] One embodiment in which the first and second needles 650 and 650′are separately actuable such that each needle is deployed independentlyof the other needle at different times is schematically illustrated inFIGS. 74B and 76A. The handle 900 of FIGS. 74B and 76A closely mirrorsthat of FIGS. 74A, 75A, and 75B, but includes a pair of needle drivers905, 905′ each with a thumb ring 903, 903′, a needle driver distal end907, 907′, and a needle holding aperture 927, 927′, respectively. Eachneedle driver 905, 905′ also has a driver peg 939, 939′. The needledrivers 905, 905′ each have a needle (not shown) connected to the needleholding aperture 927, 927′ of its needle driver distal end 907, 907′.The combination of the needle drivers 905, 905′ of the embodiment ofFIGS. 74B and 76A is similar to the plunger 904 of FIGS. 74A, 75A and75B. However, the needle drivers 905, 905′ are adapted to be slidablydisplaced relative to one another and to the handle 900, therebyseparately actuating the two needles 650, 650′.

[0338] As shown in FIG. 74B, the needle driver distal ends 907, 907′ ofthe needle drivers 905, 905′ are slidably received through the rotator930, the floater 920, the floater clamp lock 922 and the floater clamp(not shown), similar to the single plunger 704 of the embodiment of FIG.60 and the single plunger 904 of the embodiment of FIG. 74A. The driverpegs 939, 939′ are slidably received along the L-shaped lock recess 940formed on the interior of the main housing 910.

[0339] While the handle 900 is in its initial state and shipped toend-users, the driver pegs 939, 939′ within the L-shaped lock recess 940prevent the needle plungers 905, 905′ from moving distally relative tothe main housing 910. When a physician rotates the rotator 930 clockwiseby twisting the rotator grip 928, the driver pegs 939, 939′ movecircumferentially along the L-shaped lock recess 940 until the driverpegs 939, 939′ are positioned to slide distally down the longitudinalpart of the L-shaped lock recess 940. In this position, the needledrivers 905, 905′ can be moved longitudinally relative to the mainhousing 910 and relative to each other. The distal movement of theneedle drivers 905, 905′ cause the needles 650, 650′ to advancedistally, penetrate the biological tissue, and engage the suture clasparms 630, 630′ (FIGS. 77 and 78). In this way, the needles 650, 650′ canbe non-simultaneously actuated by individually advancing the needledrivers 905, 905′ at different times. The driver pegs 939, 939′ of theembodiment illustrated in FIGS. 74B and 76A operate in a similar manneras do the plunger pegs 938 described above for the use and operation ofthe embodiment illustrated in FIGS. 74A, 75A, and 75B.

[0340] FIGS. 76B-D schematically illustrate various embodiments of theneedle drivers 905, 905′. In certain embodiments, the two needle drivers905, 905′ are slidably interlocked with one another along at least aportion of their length. The embodiment illustrated in FIG. 76B hasneedle drivers 905, 905′ which utilize a interlocking claspconfiguration. Other embodiments may utilize tongue-in-grooveconfigurations, or axially concentric needle drivers 905, 905′. Personsskilled in the art can select an appropriate interlocking configurationfor the needle drivers 905, 905′.

[0341] In other embodiments, as schematically illustrated in FIG. 76C,one or both needle drivers 905, 905′ can have a raised area 909 on thesurface which is in proximity to the other needle driver. Such a raisedarea 909, 909′ can serve to reduce the sliding friction between the twoneedle drivers 905, 905′, thereby facilitating the independent actuationof the needle drivers 905, 905′. While the raised areas 909, 909′illustrated in FIG. 76C extends along the surface of the needle driverin the axial direction, other embodiments can utilize raised bumps onthis surface. Persons skilled in the art can select an appropriateraised area 909, 909′ for the needle drivers 905, 905′.

[0342] In other embodiments, each needle driver 905, 905′ is configuredto have a needle holder 911, 911′ which is separately manufactured fromthe remaining portion of the needle driver 905, 905′. As schematicallyillustrated in FIG. 76D, each needle driver distal end 907, 907′includes a recess 913 which is configured to mate and lock with a flange917, 917′ of the needle holder 911, 911′. In this way, the needleholders 911, 911′ can be fixedly attached to needles, and the needledrivers 905, 905′ can be releasably attached to the needle holders 911,911′.

[0343] The suturing device of FIGS. 77-78 may be advantageously used tosuture two biological tissue portions that are not proximal to oneanother, as shown in FIGS. 79-81. FIG. 79 illustrates the suture deviceof FIG. 77 with the first needle 650 penetrating a first surface of afirst biological tissue structure or portion 952 and advancing through asecond surface of the tissue portion 952. The distal end portion of theneedle 650 is circumferentially surrounded by the suture material (endportion of the suture 40) held by the first suture clasp arm 630.

[0344] As described herein, the end portion of the suture 40 may be, forexample, a loop with an opening or some other molded shape with orwithout an opening. In one embodiment, the opening formed in the endportion of the suture 40 has a diameter that is approximately the sameas the diameter of the distal end portion of the needle 650. In anotherembodiment, the opening formed in the end portion of the suture 40 has adiameter that is smaller than the diameter of the distal end portion ofthe needle 650 As described above, the needle 650 captures the end ofthe suture 40 lying within the suture clasp arm 630. The needle 650 thenmoves proximally into the suture introducer head 522 and withdraws theend of the suture 40 from the second surface and the first surface ofthe first tissue portion 952 and into the suture introducer head 522.

[0345]FIG. 80 illustrates the suture device of FIG. 77 with the secondneedle 650′ piercing a second biological tissue portion 950 and engagingthe second suture clasp arm 630′. The needle 650′ captures the end ofthe suture 40 lying within the suture clasp arm 630′ and withdraws theend of the suture 40 into the suture introducer head 522 as the needle650′ moves proximally into the suture introducer head 522.

[0346]FIG. 81 illustrates the first and second biological tissueportions 950, 952 being drawn together by a suture inserted by thesuture device of FIG. 77. A knot or clip may be slid down the suture 40to secure the suture site. In another embodiment, the suture ends may bemelted near the suture site to secure the suture site.

[0347] The four-, six- and eight-arm suture device embodiments describedherein may also be configured to move each needle at different times. Insome embodiments, the needles may be configured to move two or more at atime.

[0348] In the embodiments described above, the needles may be drawnproximally all the way until they are completely removed from the hollowtubular body 514 while the suture introducer head 522 is still proximalto the suture site.

[0349] Patch

[0350] In the embodiments described herein, the suturing devices may beused with a patch to facilitate closure, for example, of a surgicalsite, or other opening, including natural openings that are the resultof a congenital defect, such as cardiac septal defects. For example,FIG. 82A illustrates the suture device of FIG. 77 with a patch 954. Thepatch 954 may comprise a flexible synthetic material, such as, forexample, Gortex or Dacron, or a harvested piece of natural tissue. Inone embodiment, the patch 954 is preloaded within the suture introducerhead 522, threaded onto the suture 40, and deployed from the distal endof the suture introducer head 522. FIG. 82B illustrates the patch 954 ofFIG. 82A occluding the suture site as the ends of the suture 40 aredrawn proximally. When the ends of the suture 40 are drawn and a knot orclip is slid down to secure the suture site, the patch 954 provides animproved suture closure site.

[0351] Alternatively, as illustrated in FIGS. 83A and 83B, a patch 955can be positioned on the proximal side of tissue structures 950, 952after the suture 40 has been pulled proximally through tissue structures950, 952. For example, as described above in conjunction with FIGS.79-80, the suture 40 extends through both tissue structures 950, 952 andout of the body, as illustrated in FIG. 83A. The physician can threadthe suture 40 through corresponding apertures in a patch 955 and thenpush the patch 955 distally along the suture 40. Once the patch 955 isin proximity to the proximal side of the tissue structures 950, 952, thepatch 955 can be secured to the suture site by drawing the suture 40 andsliding distally a knot or clip to securely hold the patch 955 in place,as illustrated in FIG. 83B.

[0352] The patch may be implemented with the 4, 6, and 8-arm suturedevice embodiments described above. For example, FIG. 84 illustrates apatch 958 with two pairs of sutures 40, 40′ through the patch 958. Thepatch 958 of FIG. 84 may be used with the four-arm suture deviceembodiments described above with reference to FIGS. 58-59 or FIGS.66-69.

[0353] Steerable or Guidable Portion

[0354] In the embodiments described herein, the suturing devices mayhave a steerable or guidable portion for placing sutures at desiredsuture sites. The steerable portion is particularly advantageous toplace sutures in biological structures that are difficult to suturebecause the biological structures are either deep within a patient'sbody, substantially apart from one another and/or at an entry angle thatis difficult to access. FIG. 85 illustrates a suture device with asteerable portion 956, such as the hollow elongated body 514 asdescribed above with reference to FIGS. 52A-52B. In FIG. 85, thesteerable, hollow elongated body 956 comprises a movable, guide wirewithin a lumen of the body 956. The guidewire may be remotelymanipulated by a physician outside of the patient's body, either by ahandle that is similar to the handles described herein or some othercontrol mechanism.

[0355]FIG. 85 illustrates the steerable portion bending to the right anda first needle 650 piercing a first biological tissue portion 952. FIG.86 illustrates the steerable portion bending to the left and a secondneedle 650 piercing a second biological tissue portion 950. In FIGS.85-86, the guide wire is configured to move the suture introducer head522 in 2-dimensions. In another embodiment, the guide wire is configuredto move the suture introducer head 522 in 3 dimensions.

[0356] Methods of Forming Suture Ends

[0357] FIGS. 87-102 illustrate methods of forming suture ends of asuture which may be used with the suture devices described herein. InFIG. 87, one embodiment of the suture is a strand 1100 of deformablematerial that is preferably monofilament, such as Deklene (fromGenzyme), Prolene (from Johnson & Johnson), or Nylon (from Johnson &Johnson). In one embodiment, the strand 1100 is advantageouslyapproximately 0.010″ thick and has a length that makes it suitable foruse in a suture procedure. The strand 1100 is brought near a stream ofhot gas 1120, which may be, in one embodiment, 500° F. air ejected from,for example, nozzles 1130.

[0358] In FIG. 88, as the distal end of the strand 1100 is impacted bythe gas 1120, the distal end melts or is otherwise plastically orthermally deformed to form a locally deformed region 1140 (such as aglobule) that is broader than the rest of the strand 1100 in at leastone dimension (i.e., at least one dimension of the strand 1100 has beenincreased). By pushing the distal end of the strand 1100 into the streamof gas 1120 (e.g., by about 2 mm), the strand 1100 substantially meltsback on itself. Once the deformed region 1140 is formed, the strand 1100may be removed from the presence of the hot gas 1120 and allowed tocool. As an alternative to using the hot gas 1120, the strand 1100 maybe brought into contact with a hot metal or other solid material, suchas a soldering iron (not shown), whereupon the strand 1100 is deformedsimilar to the strand of FIG. 88.

[0359] Next, the deformed region 1140 may be flattened, and a hole oreyelet is formed therein, as illustrated in FIGS. 89-94. Alternatively,the deformed region 1140 may be formed into a cup-like member asdiscussed below in connection with FIGS. 95-98. FIG. 89 illustrates adie 1200 used for flattening the deformed region 1140. The die 1200 hasa relief or recessed portion 1210 for accepting the strand 1100 and thedeformed region 1140, as illustrated in FIG. 90. A block 1250, whichpreferably also has a recessed portion 1252 that mates with the recessedportion 1210, may then be placed over the deformed region 1140. Thealigning of the respective recessed portions 1210 and 1252 isfacilitated by a plurality of posts 1254 in the die 1200 which mate withrespective holes 1256 in the block 1250. Thus, the deformed region 1140is squeezed between the die 1200 and the block 1250, resulting in aflattened distal portion 1260 (FIG. 91) that preferably has a thicknessthat matches the rest of the strand 1100. The edges of flattened distalportion 1260 may then be trimmed to form a circular, smooth disc portion1270 (FIG. 92) to reduce the risk of such edges snagging on vessel wallsduring suturing procedures.

[0360] As illustrated in FIG. 93, a hole or eyelet 1280 may be formedout of the distal end of the strand 1100. A punch (not shown) such as ahypotube may be used to poke through the distal portion 1270, therebyleaving the eyelet 1280 in an eyelet portion 1290 at the distal end ofthe strand 1100. The eyelet 1280 is formed such that a surgical hook orneedle as described above may pass through the eyelet in a suturingprocedure. The eyelet portion 1290 acts as a connector to the hook orneedle, allowing the strand 1100 to be picked up by the hook or needle.The method of forming the eyelet 1280 described herein, including theforming of the deformed region 1140, advantageously results in nosignificant reduction in the mechanical strength of the strand 1100,with the material throughout the strand 1100 (including the material inthe eyelet portion 1290) having substantially uniform mechanicalstrength.

[0361] Advantageously, the suture embodiment shown in FIG. 93 has noknots or ties formed therein which might increase the profile of thesuture strand 1100 or make it easier for the suture to snag during use.This process may be advantageously repeated at the proximal end of thestrand 1100, resulting in eyelets 1280 at both ends of the strand 1100,as illustrated in FIG. 94. The eyelet portion 1290 at one or more of theends of the strand 1100 may be bent (not shown) at an angle with respectto the rest of the strand to facilitate the guiding of a surgical needlethrough the eyelet 1280.

[0362] FIGS. 95-102 illustrate another embodiment of forming suture endportions. In FIGS. 95-102, the deformed region 1140 (FIG. 87) may beformed into a cup-like member having a recess therein for receiving aneedle. In FIG. 95, the deformed region 1140 is compressed on its sidesby blocks 1300 which have recessed portions 1310. The blocks 1300squeeze the deformed region 1140 to form a substantially cylindricallyshaped member 1320, as shown in FIG. 96.

[0363] One end of the member 1320 may be cut off to form a flat top1330, which may then be punched or bored out with a hypotube 1340 toform a suture that comprises a cup-like member 1335 having a recess1350, as illustrated in FIGS. 97-98. In one embodiment, the cup-likemember 1335 has a height of 0.032″ and an outside diameter of0.032±0.010.″ The recess 1350 is advantageously sized to accept a distalend portion 1370 of a needle 1360 shown in FIGS. 99-101. The surgicalneedle 1360 has a main shaft portion connected to the distal end portion1370. Knurling or barbs are provided on the distal end portion 1370. Inthis way, when the surgical needle is inserted into the member 1320 (seeFIG. 101), the surgical needle digs into the sides of the cup shapedrecess and resists the tendency to be withdrawn from the member 1320.The outside diameter of the member 1320 and the outside diameter of theshaft portion of the surgical needle 1360 (i.e. the portion proximal tothe barbs) may advantageously have substantially the same diameter, sothat when the needle 1360/member 1320 combination (see FIG. 101) iswithdrawn from the patient, the possibility that the needle/membercombination will snag on tissue is reduced.

[0364] The method of forming the cup-like member 1335 described herein,including the forming of the recess 1350, advantageously results in nosignificant reduction in the mechanical strength of the strand 1100,with the material throughout the strand 1100 (including the material inthe member 1335) having substantially uniform mechanical strength. Noknots or ties are necessary. Both ends of the strand 1100 may be formedwith cup-like members 1335, as illustrated in FIG. 102. The cup-likemember 1335 at one or more of the ends of the strand 1100 may be bent(not shown) at an angle with respect to the rest of the strand tofacilitate the guiding of a surgical needle into the recess 1350.

[0365] Suspension of Body Tissue

[0366] Independent actuation of the arms can be advantageously used toattach or suspend a biological structure, such as a tissue structure oran implantable material. Examples of such procedures include, but arenot limited to, attaching a first tissue structure to a second tissuestructure, or attaching an implantable material, which can be asynthetic material or natural tissue, to a tissue structure. The tissuestructures used in this method can include bones, ligaments, muscletissue, and body organs. In operation, a suture portion 1410 is pulledthrough a tissue structure 1420 for use as an anchor as illustrated inFIG. 103A. One of the arms 1430 is deployed on one side of the tissuestructure 1420 and the corresponding needle 1440 is extended through thetissue structure 1420 to capture the suture portion 1410.

[0367] A second suture portion 1410′ can then be looped around abiological structure 1460. As illustrated in FIG. 103A, the second arm1430′ is deployed on one side of the biological structure 1460, and thecorresponding needle 1440′ is extended on the other side of thebiological structure 1460, such that the arm 1430′, the needle 1440′,and the elongated body 1470 encircle the biological structure 1460. Thesecond suture portion 1410′ is retrieved from the arm 1430′ by theneedle 1440′ to form a suture loop around the biological structure 1460.In certain embodiments, the suture portions 1410, 1410′ are pulled andtied together forming a knot, bringing the tissue structure 1420 andbiological structure 1460 together as illustrated in FIG. 103B. Incertain embodiments, rather than piercing the tissue structure 1420, thefirst arm 1430 and needle 1440 can be used to loop a suture portion 1410around the tissue structure 1420.

[0368] It will be appreciated that the arms 1430 and 1430′ can bedeployed in any preferred sequence, and that needles 1440 and 1440′ canretrieve the suture portions 1410, 1410′ in any preferred sequence. Itwill also be appreciated that the arms 1430 and 1430′ can be deployedeither simultaneously or non-simultaneously, and that the needles 1440and 1440′ can be deployed either simultaneously or non-simultaneously.

[0369] The embodiment of FIGS. 103A and 103B may also be used forsuspending an organ from an adjacent tissue structure, such as, forexample, in the treatment of bladder or uterine prolapse. Organsuspension may be accomplished with this embodiment by positioning anarm and extending a needle into an organ to retrieve a first end of asuture, moving the suturing device to traverse a space, and thenpositioning a second arm and extending a second needle around a ligamentto loop the second end of the suture around the ligament. By tighteningthe suture, the organ is suspended by using the ligament. In othersimilar embodiments, other biological structures, such as harvestedpieces of natural tissue, or synthetic material structures can besuspended or connected to existing body tissue.

[0370] While embodiments and applications of this invention have beenshown and described, it will be apparent to those skilled in the artthat various modifications are possible without departing from the scopeof the invention. It is, therefore, to be understood that within thescope of the appended claims, this invention may be practiced otherwisethan as specifically described.

What is claimed is:
 1. A suturing apparatus, comprising: an elongatebody; first and second arms, each of said arms having a suture mountingportion which mounts an end portion of a suture, said arms being mountedon the elongate body such that said suture mounting portions are movableaway from said body to a first position and towards said body to asecond position; first and second needles, each of said needles having adistal end, and being mounted such that the distal end of the needle ismovable (i) in a proximal to distal direction from a position adjacentsaid elongate body to a position spaced outwardly from said body and(ii) towards the suture mounting portion of one of the arms when in saidfirst position, wherein the respective distal ends of the first andsecond needles engage respective end portions of said suture; and anactuator which drives the needles in said proximal to distal directionsuch that the engagement of the respective end portions of the suture isnon-simultaneous.
 2. The apparatus of claim 1, wherein said actuatorcomprises a pair of independently movable needle drivers coupled toindependently advance said needles, respectively, in said proximal todistal direction.
 3. The apparatus of claim 2, wherein said needledrivers are slidably coupled to one another.
 4. A suturing apparatus,comprising: an elongate body; first and second arms, each of said armshaving a suture mounting portion which mounts an end portion of asuture, said arms being operably connected to the elongate body suchthat said suture mounting portions are movable away from said body to afirst position and towards said body to a second position; first andsecond needles, each of said needles having a distal end, and beingmounted such that the distal end of the needle is movable (i) in aproximal to distal direction from a position adjacent said elongate bodyto a position spaced outwardly from said body and (ii) towards thesuture mounting portion of one of the arms when in said first position;and an actuator comprising first and second needle drivers connected todrive the first and second needles, respectively, in said proximal todistal direction, said needle drivers being independently actuable suchthat the first needle is movable independent of the second needle.
 5. Adevice for suturing biological tissue, comprising: an elongated body; anarm operably connected to the elongated body to move to an extendedposition away from the elongated body and to a retracted position towardthe elongated body, the arm having a mounting portion which mounts aportion of a suture, and having a tissue contacting surface which facesproximally when the arm is in the extended position, said tissuecontacting surface having a projecting portion configured to provideintimate contact with said tissue and to thereby inhibit lateralmovement of said arm when said tissue contacting surface is pressedagainst tissue; and a needle having a distal end which is movabledistally from a position adjacent the elongated body towards saidmounting portion of said arm when the arm is in the extended position,such that said distal end engages said portion of the suture mounted bysaid mounting portion.
 6. The device of claim 5, wherein the projectingportion is defined by a curvature in the tissue contacting surface ofthe arm.
 7. The device of claim 5, wherein the projecting portion is atan end of the arm.
 8. The device of claim 5, wherein the projectingportion is small compared to the area of the tissue contacting surfaceof the arm.
 9. The device of claim 5, wherein the projecting portion isin proximity to the mounting portion of the arm.
 10. The device of claim5, wherein the distal end of the needle follows a path which divergesfrom a central axis of the elongated body.
 11. The device of claim 5,further comprising: a second arm operably connected to the elongatedbody to move to an extended position away from the elongated body and toa retracted position toward the elongated body, the second arm having amounting portion which mounts a second portion of said suture, andhaving a tissue contacting surface which faces proximally when thesecond arm is in the extended position; and a second needle having adistal end which is movable from a position adjacent the elongated bodytowards the mounting portion of the second arm when the second arm is inthe extended position, such that the distal end engages the secondportion of the suture mounted by the mounting portion of the second arm.12. The device of claim 11, wherein the second tissue contacting surfacehas a projecting portion configured to provide intimate contact withsaid tissue and to thereby inhibit lateral movement of said second arm.13. The device of claim 12, wherein the projecting portion of the secondtissue contacting surface is at an end of the second arm.
 14. The deviceof claim 12, wherein the projecting portion of the second tissuecontacting surface is small compared to the area of the second tissuecontacting surface.
 15. The device of claim 12, wherein the projectingportion of the second tissue contacting surface is in proximity to themounting portion of the second arm.
 16. The device of claim 11, whereinthe first needle and second needle are configured to movesimultaneously.
 17. The device of claim 11, wherein the first needle andsecond needle are configured to move at different times.
 18. The deviceof claim 11, wherein the first needle engages the first portion of thesuture before the second needle engages the second portion of thesuture.
 19. The device of claim 11, wherein the first needle engages thefirst portion of the suture before the second needle moves towards themounting portion of the second arm.
 20. The device of claim 11, whereinthe first arm and second arm are configured to move at different times.21. The device of claim 5, further comprising: second, third, and fourtharms operably connected to the elongated body to move to an extendedposition away from the elongated body and to a retracted position towardthe elongated body, the second arm having a mounting portion whichmounts a second portion of said suture, the third and fourth arms eachhaving a mounting portion which respectively mounts a first and secondportion of a second suture, and the second, third, and fourth arms eachhaving a tissue contacting surface which faces proximally when therespective arm is in the extended position; and second, third and fourthneedles each having a distal end which is movable from a positionadjacent the elongated body towards the mounting portions of the second,third, and fourth arms, respectively, when the respective arm is in theextended position, such that the distal end of each needle engages theportion of the sutures mounted by the mounting portion of the respectivearm and to thereby inhibit lateral movement of the respective arm whenthe tissue contacting surface is pressed against the tissue.
 22. Thedevice of claim 21, wherein the tissue contacting surface of each armhas a projecting portion configured to provide intimate contact withsaid tissue and to thereby inhibit lateral movement of the respectivearm.
 23. A suturing apparatus comprising: an elongated body; an armoperably connected to the elongated body and movable relative to theelongated body to an extended position away from the elongated body andto a retracted position towards the elongated body, the arm having amounting portion which mounts a portion of a suture; a needle movablerelative to the elongated body, the needle having a distal end movablefrom a position adjacent the elongated body towards the mounting portionof the arm when the arm is in the extended position, such that thedistal end engages the portion of the suture mounted by the mountingportion of the arm; and a patch which is tethered by the suture.
 24. Thesuturing apparatus of claim 23, wherein the patch is stored within theelongated body for deployment from a distal end portion of the elongatedbody.
 25. The suturing apparatus of claim 23, wherein the patchcomprises a flexible piece of synthetic material or natural tissue. 26.A method of suturing comprising: providing an elongate body having firstand second arms which mount first and second portions, respectively, ofa suture; engaging the first and second portions of the suture withfirst and second needles, respectively, by driving the first and secondneedles towards the first and second arms, respectively, in a proximalto distal direction, the engaging comprising engaging the first portionof suture with the first needle prior to engaging the second portion ofthe suture with the second needle.
 27. The method of claim 26, furthercomprising moving the first arm away from the elongate body, and movingthe second arm away from the elogate body.
 28. The method of claim 27,wherein the first arm is moved away from the elongate body before thesecond arm is moved away from the elongate body.
 29. The method of claim26, wherein the first needle drives towards the first arm before thesecond needle engages the second portion of the suture.
 30. The methodof claim 26, wherein the first needle drives towards the first armbefore the second needle drives towards the second arm.
 31. The methodof claim 26, wherein engaging the first portion of the suture with thefirst needle comprises penetrating a tissue structure with the firstneedle.
 32. The method of claim 31, wherein engaging the second portionof the suture with the second needle comprises penetrating a secondtissue structure with the second needle.
 33. The method of claim 31,wherein engaging the second portion of the suture with the second needlecomprises extending the second needle along a side of a second tissuestructure, such that the second arm, second needle, and elongate bodyencircle the second tissue structure.
 34. The method of claim 31,wherein engaging the second portion of the suture with the second needlecomprises extending the second needle along a side of an implantablematerial, such that the second arm, second needle, and elongate bodyencircle the implantable material.
 35. The method of claim 34, whereinthe implantable material comprises synthetic material.
 36. The method ofclaim 34, wherein the implantable material comprises natural tissue. 37.The method of claim 26, wherein engaging the second portion of thesuture with the second needle comprises penetrating a tissue structurewith the second needle.
 38. The method of claim 37, wherein engaging thefirst portion of the suture with the first needle comprises extendingthe first needle along a side of a second tissue structure, such thatthe first arm, first needle, and elongate body encircle the secondtissue structure.
 39. The method of claim 37, wherein engaging the firstportion of the suture with the first needle comprises extending thefirst needle along a side of an implantable material, such that thefirst arm, first needle, and elongate body encircle the implantablematerial.
 40. The method of claim 39, wherein the implantable materialcomprises synthetic material.
 41. The method of claim 39, wherein theimplantable material comprises natural tissue.
 42. The method of claim26, wherein engaging the first portion of the suture with the firstneedle comprises extending the first needle along a side of a firsttissue structure, such that the first arm, first needle, and elongatebody encircle the first tissue structure and engaging the second portionof the suture with the second needle comprises extending the secondneedle along a side of a second tissue structure, such that the secondarm, second needle, and elongate body encircle the second tissuestructure.
 43. The method of claim 26, wherein engaging the firstportion of the suture with the first needle comprises extending thefirst needle along a side of a first tissue structure, such that thefirst arm, first needle, and elongate body encircle the first tissuestructure and engaging the second portion of the suture with the secondneedle comprises extending the second needle along a side of animplantable material, such that the second arm, second needle, andelongate body encircle the implantable material.
 44. A method ofoccluding a septal defect, the method comprising: inserting a distal endportion of an elongated body into an opening in a living being;positioning the distal end portion in a first location adjacent a firsttissue portion in proximity to the septal defect; deploying a firstneedle within the elongated body so as to draw a first end of a suturethrough the first tissue portion; moving the distal end portion to asecond location displaced from the first location and positioning thedistal end portion adjacent a second tissue portion in proximity to theseptal defect; deploying a second needle within the elongated body so asto draw a second end of the suture through the second tissue portion;and using the suture to secure a patch across the septal defect.
 45. Themethod of claim 44, wherein securing the patch comprises pulling theends of the suture to draw the patch against the first and second tissueportions.
 46. The method of claim 44, wherein the septal defect is acongenital heart defect.
 47. The method of claim 44, wherein using thesuture to secure the patch across the septal defect comprises: deployingthe patch from the distal end of the elongated body, the patch beingpreloaded and threaded onto the suture; and pulling the suture andsliding a knot or clip toward the septal defect to securely hold thepatch in place.
 48. The method of claim 44, wherein using the suture tosecure the patch across the septal defect comprises: passing the firstand second ends of the suture through the patch; pushing the patchdistally along the suture toward the septal defect; and pulling thesuture and sliding a knot or clip toward the septal defect to securelyhold the patch in place.
 49. A method of suturing, comprising: insertinga distal end portion of an elongated body into an opening in a livingbeing; positioning the distal end portion in a first location adjacent afirst tissue portion; deploying a first needle within the elongated bodyso as to draw a first end of a suture through the first tissue portion;moving the distal end portion to a second location displaced from thefirst location and positioning the distal end portion adjacent a secondtissue portion; deploying a second needle within the elongated body soas to draw a second end of the suture through the second tissue portion;and using the suture to secure a patch to the first and second tissueportions.
 50. The method of claim 49, wherein using the suture to securea patch to the first and second tissue portions comprises pulling thesuture through the patch prior to inserting the distal end portion ofthe elongated body into the opening in the living being.
 51. The methodof claim 49, wherein the method further comprises: pushing the patchdistally along the suture to be in proximity to the first and secondtissue portions; and occluding a space between the first and secondtissue portions by sliding a knot or clip toward the patch to securelyhold the patch in place.
 52. A method of suspending a biologicalstructure, comprising: positioning a distal portion of an elongated bodyadjacent the biological structure to be suspended; positioning a firstarm operably connected to the elongated body on one side of thebiological structure, the first arm releasably holding a first endportion of a suture; extending a first needle toward the first endportion of the suture in the first arm, the first needle moving on anopposite side of the biological structure such that when the firstneedle engages the first end portion of the suture, the biologicalstructure is encircled by the first arm, the first needle, and theelongated body; positioning a second arm operably connected to theelongated body adjacent a tissue portion, the second arm releasablyholding a second end portion of the suture; extending a second needlethrough the tissue portion to engage the second end portion of thesuture in the second arm; drawing the first end portion and second endportion of the suture toward the elongated body; and tying the first endportion and second end portion of the suture to suspend the biologicalstructure to the tissue portion.
 53. A method of placing a suture aroundthe exterior of a biological structure, the method comprising: advancingan elongate suturing device having an elongate body distally towards thebiological structure; positioning a first suture portion mounted on theelongate device so that the first suture portion is proximate thebiological structure; advancing a suture retrieving member of theelongate device past the biological structure without piercing thebiological structure, said advancing comprising moving the sutureretrieving member with the biological structure between the sutureretrieving member and the elongate body, said advancing furthercomprising coupling the suture retrieving member to the first sutureportion; drawing the first suture portion away from the biologicalstructure by moving the suture retrieving member in a direction awayfrom the biological structure; and drawing a second suture portion awayfrom the biological structure by moving at least a portion of theelongate device from the biological structure, whereby the sutureextends in a loop around the biological structure.
 54. The method ofclaim 53, wherein advancing the suture retrieving member past thebiological structure comprises moving the suture retrieving member in adistal to proximal direction, and drawing the first suture portion awayfrom the biological structure comprises moving the suture retrievingmember in a proximal direction.
 55. The method of claim 53, whereinadvancing the suturing device distally towards the biological structurecomprises advancing the suturing device into a body cavity of a livingbeing.
 56. The method of claim 55, wherein the biological structurecomprises a synthetic material.
 57. The method of claim 53, wherein thefirst and second suture portions are mounted on respective armsextending from the elongate body.
 58. The method of claim 53, whereinthe biological structure comprises an elongate structure.
 59. The methodof claim 58, wherein the elongate structure comprises a ligament. 60.The method of claim 53, further comprising tying the first and secondsuture portions together to form a knot.
 61. The method of claim 53,wherein the suture retrieving member comprises a needle.